82 FR 28322 - Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 118 (June 21, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 118 (June 21, 2017)
| Page Range | 28322-28329 | |
| FR Document | 2017-12908 |
[Federal Register Volume 82, Number 118 (Wednesday, June 21, 2017)] [Notices] [Pages 28322-28329] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12908] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-3203] Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 121 new drug applications (NDAs) and 161 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: The withdrawal is effective on July 21, 2017. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601. SUPPLEMENTARY INFORMATION: The holders of the applications listed in table 1 in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under Sec. 314.150(c) is without prejudice to refiling. [[Page 28323]] Table 1 ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ NDA 005897............. Folvite (folic acid) Wyeth Pharmaceuticals Injection, 5 Inc., Subsidiary of milligrams (mg)/ Pfizer Inc., P.O. Box milliliter (mL). 8299, Philadelphia, PA 19101-8299. NDA 006343............. Wydase (hyaluronidase) Baxter Healthcare Injection USP. Corp., 32650 N. Wilson Rd., Round Lake, IL 60073. NDA 007390............. Banthine (methantheline Shire Development bromide) Tablets, 50 Inc., 725 mg. Chesterbrook Blvd., Wayne, PA 19087. NDA 008126............. Cortisone Acetate Pharmacia & Upjohn (cortisone acetate) Co., Subsidiary of Tablets, 5 mg, 10 mg, Pfizer Inc., 235 East and 25 mg; and 42nd St., New York, Injection, 25 mg/mL. NY 10017. NDA 008732............. Pro-Banthine Shire Development Inc. (propantheline bromide) Tablets, 7.5 mg and 15 mg. NDA 011683............. Thiotepa for Injection, Immunex Corp., 15 mg/vial. Subsidiary of Amgen, 1 Amgen Center Dr., MS 17 1B, Thousand Oaks, CA 91320-1799. NDA 011836............. Presamine (imipramine Sanofi-Aventis U.S. hydrochloride (HCl)) LLC, 55 Corporate Tablets USP. Dr., Bridgewater, NJ 08807. NDA 012003............. Akineton (biperiden AbbVie Inc., 1 N. HCl) Tablets, 2 mg. Waukegan Rd., Dept. PA77/Bldg. AP30-1, North Chicago, IL 60064. NDA 012421............. Medrol Acetate Pharmacia & Upjohn Co. (methylprednisolone acetate) Topical Ointment, 0.25% and 1%. NDA 013935............. Herplex (idoxuridine) Allergan, Inc., 2525 Ophthalmic Solution, Dupont Dr., P.O. Box 0.1%. 19534, Irvine, CA 92623-9534. NDA 013993............. Chromitope Sodium Bracco Diagnostics (sodium chromate Cr Inc., 259 Prospect 51) Injection USP, 2 Plains Rd., Bldg. H, millicuries (mCi)/vial Monroe Township, NJ and 200 microcuries 08831. (uCi)/mL. NDA 014006............. Maxibolin Organon USA, Inc., (ethylestrenol) Subsidiary of Merck & Elixir, 2 mg/5 mL. Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033. NDA 014214............. NegGram (nalidixic Sanofi-Aventis U.S. acid) Tablets USP, 250 LLC, c/o Sanofi U.S. mg, 500 mg, and 1 gram Services Inc., 55 (g). Corporate Dr., Bridgewater, NJ 08807. NDA 014295............. Conray 400 (iothalamate Mallinckrodt Inc., 675 sodium) Injection USP, McDonnell Blvd., 66.8%. Hazelwood, MO 63042. NDA 016089............. Rubratope-57 Bracco Diagnostics (cyanocobalamin CO-57) Inc. Capsules, 0.5-1 uCi and Rubratope-57 Kit (cobalt chloride CO- 57, cyanocobalamin, cyanocobalamin CO-57, intrinsic factor). NDA 016672............. Ovral (ethinyl Wyeth Pharmaceuticals estradiol and Inc. norgestrel) Tablets, 0.05 mg/0.5 mg. NDA 016692............. M/6 Sodium Lactate Baxter Healthcare (sodium lactate) Corp. Injection USP, 1.87 g/ 100 mL. NDA 016696............. Dextrose 10% and Sodium Do. Chloride 0.9% Injection USP in Plastic Container. NDA 016708............. Sodium Chromate Cr 51 Mallinckrodt Nuclear Injection, 100 Medicine LLC., 2703 [micro]Ci/mL. Wagner Place, Maryland Heights, MO 63043. NDA 016744............. Noriday 1+50 FE GD Searle LLC, (mestranol and Subsidiary of Pfizer norethindrone) Tablets. Inc., 235 East 42nd St., New York, NY 10017. NDA 016806............. Ovral-28 (ethinyl Wyeth Pharmaceuticals estradiol and Inc. norgestrel) Tablets, 0.05 mg/0.5 mg. NDA 016860............. Eskalith (lithium Noven Therapeutics, carbonate) Capsules, LLC., 11960 Southwest 300 mg. 144th St., Miami, FL 33186. NDA 017038............. Sodium Chloride B. Braun Medical Inc., Injection, 20 g/100 mL. 901 Marcon Blvd., Allentown, PA 18109. NDA 017281............. Technetium Tc99m Lantheus Medical Generator (Neutron). Imaging, Inc., 331 Treble Cove Rd., North Billerica, MA 01862. NDA 017283............. Xenon Xe 133 Injection, Lantheus Medical 6.3 mCi/mL. Imaging, Inc. NDA 017505............. Noriday (mestranol and GD Searle LLC. norethindrone) Tablets. NDA 017549............. LidoPen (lidocaine HCl) Meridian Medical Injection, 10%. Technologies, Inc., Subsidiary of Pfizer Inc., 235 East 42nd Street, New York, NY 10017. NDA 017576............. Ovcon-50 (ethinyl Warner Chilcott Co., estradiol and LLC, Union Street norethindrone ) Road, 195 km 1.1, Tablets USP, 0.05 mg/1 Fajrado, Puerto Rico mg. 00738. NDA 017670............. Sodium Chloride 0.45% Hospira, Inc. 275 in Plastic Container, North Field Dr., Lake Irrigation. Forest, IL 60045. NDA 017756............. Tylenol (acetaminophen) Johnson & Johnson Suppositories, 120 mg Consumer Inc., McNeil and 650 mg. Consumer Healthcare Division, 7050 Camp Hill Rd., Fort Washington, PA 19034. NDA 017748............. Noriday 1+50 (mestranol GD Searle LLC. and norethindrone) Tablets. NDA 018031............. Inderide (propranolol Wyeth Pharmaceuticals HCl and Inc. hydrochlorothiazide) Tablets, 40 mg/25 mg and 80 mg/25 mg. NDA 018039............. Loxitane IM (loxapine Actavis Laboratories HCl) Injection, UT, Inc., Subsidiary Equivalent to (EQ) 50 of Teva mg base/mL. Pharmaceuticals USA, Inc., 425 Privet Road, Horsham, PA 19044. NDA 018104............. Hylorel (guanadrel Pharmacia and Upjohn sulfate) Tablets, 10 Co. mg and 25 mg. NDA 018239............. Propine (dipivefrin Allergan, Inc. HCl) Ophthalmic Solution USP, 0.1%. NDA 018254............. Ringer's and Dextrose Hospira Inc. 5% (calcium chloride, dextrose, potassium chloride, sodium chloride) Injection USP (in Plastic Container). NDA 018353............. Flagyl I.V. GD Searle LLC. (metronidazole HCl) for Injection, EQ 500 mg base/vial. NDA 018388............. Lidocaine HCl in Hospira, Inc. Dextrose 5% in Plastic Container Injection. [[Page 28324]] NDA 018404............. 0.25% Acetic Acid Do. Irrigation Solution. NDA 018406............. PhysioSol (magnesium Do. chloride, potassium chloride, sodium acetate, sodium chloride, sodium gluconate) Irrigation Solution. NDA 018460............. Dialyte (Peritoneal B. Braun Medical Inc. Dialysis Solution) Pattern LM (calcium chloride, dextrose, magnesium chloride, sodium acetate, sodium chloride) with Dextrose. NDA 018465............. Soyacal (soybean oil) Grifols Biologicals Injection, 10%. Inc., 5555 Valley Blvd., Los Angeles, CA 90032. NDA 018509............. Baros (sodium Mallinckrodt Inc. bicarbonate, tartaric acid) Effervescent Granules, 460 mg/g; 420 mg/g). NDA 018713............. Mycelex (clotrimazole) Bayer Healthcare Troche/Lozenge, 10 mg. Pharmaceuticals Inc., 100 Bayer Blvd., Whippany, NJ 07981. ANDA 018730............ Indomethacin Capsules Zenith Laboratories, USP, 25 mg and 50 mg. Inc., 140 LeGrand Ave., Northvale, NJ 07647. NDA 018786............. Soyacal(Soybean Oil) Grifols Biologicals Injection, 20%. Inc., 5555 Valley Blvd., Los Angeles, CA 90032. NDA 018807............. Dialyte (Peritoneal B. Braun Medical Inc. Dialysis Concentrates) (calcium chloride, dextrose, magnesium chloride, sodium acetate, sodium chloride) with Dextrose. NDA 018887............. Intal (cromolyn sodium) King Pharmaceuticals Metered Dose Inhaler, Inc., Subsidiary of 0.8 mg/inhalation. Pfizer Inc., 235 East 42nd St., New York, NY 10017. NDA 018970............. Liposyn III 20% Hospira, Inc. (soybean oil) Injection. NDA 018991............. Liposyn II 20% Do. (safflower oil and soybean oil) Injection. NDA 018997............. Liposyn II 10% Do. (safflower oil and soybean oil) Injection. NDA 019038............. Calan (verapamil HCl) G.D. Searle LLC. Injection, 2.5 mg/mL. NDA 019121............. Bretylium Tosylate in B. Braun Medical Inc. 5% Dextrose Injection. NDA 019212............. Theophylline and 5% Do. Dextrose Injection. NDA 019229............. Zinc Sulfate Injection, Abraxis Pharmaceutical EQ 1 mg Zinc/mL. Products, 6133 North River Rd., Suite 500, Rosemont, IL 60018. NDA 019350............. Cupric Sulfate Do. Injection, EQ 0.4 mg Copper/mL. NDA 019415............. Fertinex EMD Serono, Inc., One (urofollitropin) for Technology Pl., Subcutaneous Rockland, MA 02370. Injection, 75 international units (IU)/ampule and 150 IU/ ampule, and Metrodin (urofollitropin) for Intramuscular Injection, 75 IU)/ ampule and 150 IU/ ampule. NDA 019510............. Pepcid (famotidine) Merck Sharp & Dohme Injection, 10 mg/mL. Corp., Subsidiary of Merck & Co., Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889. NDA 019514............. Ionosol T and 5% Hospira, Inc. Dextrose Injection. NDA 019515............. Ionosol B and 5% Do. Dextrose Injection. NDA 019641............. Terazol 3 (terconazole) Janssen Vaginal Suppositories, Pharmaceuticals, 80 mg. Inc., 1000 U.S. Highway 202, Raritan, NJ 08869. NDA 019643............. Mevacor (lovastatin) Merck Sharp & Dohme Tablets, 10 mg, 20 mg, Corp. and 40 mg. NDA 019660............. Tilade (nedocromil King Pharmaceuticals sodium) Metered Dose Inc. Inhaler, 1.75 mg/ inhalation. NDA 019793............. Pharmaseal Scrub Care CareFusion 2200, Inc., (chlorhexidine 75 North Fairway Dr., gluconate) Sponge, 4%. Vernon Hills, IL 60061. NDA 019802............. Heparin Sodium in B. Braun Medical Inc. Sodium Chloride Injection. NDA 019834............. Plendil (felodipine) AstraZeneca Extended-Release Pharmaceuticals LP, Tablets, 2.5 mg, 5 mg, 1800 Concord Pike, and 10 mg. Wilmington, DE 19803. NDA 019907............. Optipranolol Bausch & Lomb, Inc., (metipranolol HCl) Subsidiary of Valeant Ophthalmic Solution, Pharmaceuticals 0.3%. International, Inc., 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. NDA 019933............. Lactated Ringer's Baxter Healthcare (calcium chloride, Corp. potassium chloride, sodium chloride, sodium lactate) Irrigation Solution. NDA 020092............. Dilacor XR (diltiazem Allergan Sales, LLC, HCl) Extended-Release 2525 Dupont Drive, Capsules, 120 mg, 180 Irvine, CA 92612. mg, and 240 mg. NDA 020146............. Nitrodisc GD Searle LLC. (nitroglycerin) Transdermal System, 0.2 mg/hour (hr), 0.3 mg/hr, and 0.4 mg/hr. NDA 020181............. Liposyn III 30% Hospira, Inc. (soybean oil) Injection. NDA 020249............. Pepcid Preservative Merck Sharp & Dohme Free (famotidine) Corp. Injection, 0.4 mg/mL. NDA 020291............. Combivent (albuterol Boehringer Ingelheim sulfate and Pharmaceuticals Inc., ipratropium bromide) 900 Ridgebury Rd., Metered Dose Inhaler, P.O. Box 368, EQ 0.09 mg base/ Ridgefield, CT 06877. inhalation; 0.018 mg/ inhalation. NDA 020292............. FerriSeltz (ferric Otsuka Pharmaceutical ammonium citrate) Co., Ltd., 508 Powder for Oral Carnegie Center Dr., Solution, 600 mg/ Princeton, NJ 08540. packet. ANDA 020360............ Hepatasol Sulfite-free Baxter Healthcare (amino acids) Corp. Injection, 8%. NDA 020409............. Nasarel (flunisolide) Teva Branded Nasal Spray, 0.029 mg/ Pharmaceutical spray. Products R&D, Inc., 74 NW 176th St., Miami, FL 33169. NDA 020448............. Imodium A-D (loperamide Johnson & Johnson HCl) Tablets Consumer Inc. (Chewable), 2 mg. NDA 020506............. Tiamate (diltiazem Merck & Co., Inc., malate) Extended- P.O. Box 1000, UG2C- Release Tablets. 50, North Wales, PA 19454. [[Page 28325]] NDA 020518............. Retrovir (zidovudine) ViiV Healthcare Co., Tablets, 200 mg and Five Moore Dr., P.O. 300 mg. Box 13398, Research Triangle Park, NC 27709. NDA 020569............. Vitrasert (ganciclovir) Bausch & Lomb Inc. Implant, 4.5 mg. NDA 020606............. Imodium Multi-Symptom Johnson & Johnson Relief (loperamide HCl Consumer Inc. and simethicone) Tablets (Chewable), 2 mg/125 mg. NDA 020635............. Levaquin (levofloxacin) Janssen Injection, EQ 250 mg/ Pharmaceuticals, Inc. 50 mL, EQ 500 mg/100 mL, and EQ 750 mg/150 mL. NDA 020745............. Zantac (ranitidine HCl) Sanofi-Aventis U.S. Tablets LLC, 55 Corporate (Effervescent), EQ 75 Drive, Bridgewater, mg base. NJ 08807. NDA 020752............. Pepcid RPD (famotidine) Merck Sharp & Dohme Orally Disintegrating Corp. Tablets, 20 mg and 40 mg. NDA 020799............. Floxin Otic (ofloxacin) Daiichi Sankyo Co., Otic Solution, 0.3%. Ltd., 399 Thornall St., Edison, NJ 08837. NDA 020813............. Klonopin (clonazepam) Hoffmann La-Roche, Orally Disintegrating Inc., c/o Genentech, Tablets, 0.125 mg, Inc., 1 DNA Way MS 0.25 mg, 0.5 mg, 1 mg, #242, South San and 2 mg. Francisco, CA 94080. NDA 020902............. Pepcid AC (famotidine) Johnson & Johnson Tablets OTC, 10 mg. Consumer Inc. NDA 021097............. Visicol (sodium Salix Pharmaceuticals phosphate, monobasic Inc., Subsidiary of monohydrate, and Valeant sodium phosphate Pharmaceuticals North dibasic anhydrous) America LLC, 400 Tablets USP. Somerset Corporate Blvd., Bridgewater, NJ 08807. NDA 021214............. Rescula (unoprostone R-Tech Ueno, Ltd., c/o isopropyl) Ophthalmic Sucampo Pharma Solution, 0.15%. Americas, LLC, 805 King Farm Blvd., Suite 550, Rockville, MD 20850. NDA 021224............. Razadyne (galantamine Janssen hydrobromide) Oral Pharmaceuticals, Inc. Solution, 4 mg/mL. NDA 021317............. Bayer Extra Strength Bayer Healthcare LLC, Aspirin (aspirin) 100 Bayer Blvd., Tablets, 500 mg. Whippany, NJ 07981. NDA 021412............. Tovalt ODT (zolpidem Valeant tartrate) Orally Pharmaceuticals North Disintegrating America, LLC, 400 Tablets, 5 mg and 10 Somerset Corporate mg. Blvd., Bridgewater, NJ 08807. NDA 021453............. Zerit XR (stavudine) Bristol-Myers Squibb Extended-Release Co., 5 Research Capsules, 37.5 mg, 50 Parkway, Wallingford, mg, 75 mg, and 100 mg. CT 06492. NDA 021483............. Geodon (ziprasidone Pfizer Inc., 235 East HCl) Oral Suspension, 42nd St., New York, EQ10 mg base/mL. NY 10017. NDA 021494............. Axid (nizatidine) Oral Braintree Solution, 15 mg/mL. Laboratories, Inc., 60 Columbian St. West, P.O. Box 850929, Braintree, MA 02185. NDA 021589............. Kemstro (baclofen) UCB, Inc.,1950 Lake Orally Disintegrating Park Dr., Smyrna, GA Tablets, 10 mg and 20 30080. mg. NDA 021595............. Sanctura (trospium Allergan, Inc. chloride) Tablets, 20 mg. NDA 021721............. Levaquin (levofloxacin) Janssen Oral Solution, 25 mg/ Pharmaceuticals, Inc. mL. NDA 021763............. Citalopram Hydrobromide Valeant International Orally Disintegrating (Barbados) SRL Tablets, EQ 10 mg Welches, Christ base, EQ 20 mg base, Church, Barbados, and EQ 40 mg base. BB17154. NDA 021864............. Lybrel (ethinyl Wyeth Pharmaceuticals estradiol and Inc. levonorgestrel) Tablets, 0.02 mg/0.09 mg. NDA 022103............. Sanctura XR (trospium Allergan, Inc. chloride) Extended- Release Capsules, 60 mg. NDA 022220............. Trivaris (triamcinolone Do. acetonide) Injectable Suspension, 80 mg/mL. NDA 022294............. Zidovudine Tablets, 60 Aurobindo Pharma mg. Limited, c/o Aurobindo Pharma USA, Inc., 2400 Route 130 North, Dayton, NJ 08810. NDA 022377............. Alsuma (sumatriptan Meridian Medical succinate) Auto- Technologies, Inc., Injector, EQ 6 mg base/ 1945 Craig Rd., St. 0.5 mL Injectable. Louis, MO 63146. NDA 022411............. Oleptro (trazodone HCl) Angelini Pharma Inc., Extended-Release 8322 Helgerman Ct., Tablets, 150 mg and Gaithersburg, MD 300 mg. 20877. NDA 022494............. Sodium Fluoride F 18 National Institutes of Injection, 10-200 mCi/ Health/National mL. Cancer Institute, Cancer Imaging Program, 9609 Medical Center Dr., Room 4- W236, MSC 9729, Bethesda, MD 20892- 9729. NDA 022545............. Tekamlo (aliskiren Novartis hemifumarate and Pharmaceuticals amlodipine besylate) Corp., One Health Tablets. Plaza, East Hanover, NJ 07936. ANDA 040032............ Cyclophosphamide Roxane Laboratories, Tablets USP, 25 mg and Inc., 1809 Wilson 50 mg. Rd., Columbus, OH 43228. ANDA 040262............ Leucovorin Calcium for Pharmachemie B.V., c/o Injection, EQ 350 mg SICOR base/vial. Pharmaceuticals, Inc., 19 Hughes, Irvine, CA 92618. ANDA 040772............ Fluorouracil Injection Sandoz Inc., 100 USP, 50 mg/mL. College Road West, Princeton, NJ 08540. ANDA 040793............ A-Methapred Hospira, Inc. (methylprednisolone sodium succinate) for Injection USP, EQ 40 mg base/vial. ANDA 040827............ A-Methapred Do. (methylprednisolone sodium succinate) for Injection USP, EQ 125 mg base/vial. NDA 050182............. Erythrocin Do. (erythromycin lactobionate) for Injection USP. NDA 050435............. Geocillin Pfizer, Inc. (carbenicillin indanyl sodium) Tablets, EQ 382 mg base. NDA 050528............. Duricef (cefadroxil) Warner Chilcott Co., Tablets USP, EQ 1 g Inc., 100 Enterprise base. Drive, Rockaway, NJ 07866. NDA 050545............. Pipracil (piperacillin Wyeth Pharmaceuticals sodium) Injection. Inc. NDA 050590............. Timentin (ticarcillin GlaxoSmithKline. disodium and clavulanate potassium) for Injection. [[Page 28326]] NDA 050658............. Timentin Galaxy Plastic Do. Container(ticarcillin disodium and clavulanate potassium) for Injection. NDA 050664............. Cefzil (cefprozil) Corden Pharma Latina, Tablets, 250 mg and S.p.A. , c/o 500 mg. Clinipace, Inc., 4840 Pearl East Circle, Suite 210E, Boulder, CO 80301. NDA 050665............. Cefzil (cefprozil) Oral Do. Suspension, 125 mg/5 mL and 250 mg/5 mL. ANDA 060076............ Streptomycin Sulfate Pfizer Inc. Powder for Injection, EQ 1 g base/vial and EQ 5 g base/vial. ANDA 060111............ Streptomycin Sulfate Do. Powder for Injection, EQ 1 g base/2.5 mL. ANDA 060607............ Neomycin Sulfate Lannett Co., Inc., Tablets, 500 mg. 9000 State Rd., Philadelphia, PA 19136. ANDA 061578............ Poly-Rx (polymyxin B X-GEN Pharmaceuticals, sulfate USP) for Inc., 300 Daniel Prescription Zenker Dr., Compounding. Horseheads, NY 14845. ANDA 061580............ Baci-Rx (bacitracinUSP) Do. for Prescription Compounding. ANDA 061645............ Econochlor Alcon Laboratories, (chloramphenicol) Inc., 6201 South Ophthalmic Solution Freeway, TC-45, Fort USP, 0.5%. Worth, TX 76134-2099. ANDA 061648............ Chloramphenicol Do. Ophthalmic Ointment, 1%. ANDA 062118............ Cephalexin Capsules Do. USP, EQ 250 mg base and EQ 500 mg base. ANDA 062206............ Cefaclor for Oral Do. Suspension USP, EQ 125 mg base/5 mL, EQ 187 mg base/5 mL, EQ 250 mg base/5 mL, and EQ 375 mg base/5 mL. ANDA 062339............ Statrol (neomycin Alcon Laboratories, sulfate and polymyxin Inc. B sulfate) Ophthalmic Solution, EQ 3.5 mg base/mL and 16,250 units/mL. ANDA 062523............ Gentamicin Sulfate Do. Ophthalmic Solution USP, EQ 0.3% base. ANDA 062628............ Chloramphenicol Do. Ophthalmic Solution USP, 0.5%. ANDA 062691............ Timentin ADD-Vantage GlaxoSmithKline. (ticarcillin disodium and clavulanate potassium) for Injection USP, EQ 3 g base/vial and EQ 100 mg base/vial. ANDA 062714............ Neomycin Sulfate and Alcon Pharmaceuticals Dexamethasone Sodium Ltd., 6201 South Phosphate Ophthalmic Freeway, Fort Worth, Solution, EQ 3.5 mg TX 76134. base/mL and EQ 0.1% and. ANDA 062721............ Neomycin and Polymyxin Do. B Sulfate and Dexamethasone Ophthalmic Suspension USP, EQ 3.5 mg base/ mL; 10,000 units/mL; 0.1%. ANDA 062822............ Pediotic (neomycin Monarch sulfate and polymyxin Pharmaceuticals, B sulfate and Inc., Subsidiary of hydrocortisone) Otic Pfizer Inc., 235 East Suspension USP. 42nd St., New York, NY 10017-7555. ANDA 063176............ Tobramycin Ophthalmic Alcon Pharmaceuticals, Solution USP, 0.3%. Ltd. ANDA 063208............ Cefazolin for Injection Steri-Pharma, LLC, 429 USP, EQ 1 g base/100 South West St., mL vial. Syracuse, NY 13202. ANDA 063216............ Cefazolin for Injection Do. USP, EQ 500 mg base/ 100 mL vial. ANDA 063283............ Amikacin Sulfate Hospira, Inc. Injection, EQ 62.5 mg base/mL. ANDA 064169............ Cefazolin for Injection Fresenius Kabi USA, USP, EQ 500 mg base/ LLC, Three Corporate vial and EQ 1 g base/ Dr., Lake Zurich, IL vial. 60047. ANDA 064170............ Cefazolin for Injection Do. USP, EQ 10 g base/vial and EQ 20 g base/vial. ANDA 065010............ Neo-Fradin (neomycin X-GEN Pharmaceuticals, sulfate) Oral Solution Inc. USP, EQ 87.5 mg base/5 mL. ANDA 065011............ Cefoxitin (cefoxitin Fresenius Kabi USA, sodium) for Injection, LLC. EQ 10 g base/Vial. ANDA 065012............ Cefoxitin for Injection Do. USP, EQ 1 g base/vial and EQ 2 g base/vial. ANDA 065245............ Ceftriaxone for Do. Injection USP, EQ 250 mg base/vial, EQ 500 mg base/vial, EQ 1 g base/vial, and EQ 2 g base/vial. ANDA 065252............ Ceftriaxone for Do. Injection, EQ 10 g base/vial. ANDA 065324............ Amoxicillin Tablets for Aurobindo Pharma Oral Suspension USP, Limited. 200 mg and 400 mg. ANDA 065339............ Epirubicin HCl Sandoz, Inc. Injection, 50 mg/25 mL and 200 mg/100 mL. ANDA 065465............ Ceftriaxone for Bedford Laboratories, Injection USP, EQ 250 c/o PAREXEL mg base/vial, EQ 500 International, 4600 mg base/vial, EQ 1 g East-West Highway, base/vial, and EQ 2 g Suite 350, Bethesda, base/vial. MD 20814. ANDA 065475............ Ceftriaxone for Do. Injection USP, EQ 10 g base/vial. ANDA 070088............ Ibuprofen Tablets USP, BASF Corp., 5738 600 mg. County Rd. 4, Bishop, TX 78343. ANDA 070187............ Disopyramide Phosphate Ivax Pharmaceuticals Capsules USP, EQ 150 Inc., Subsidiary of mg base. Teva Pharmaceuticals USA, Inc., 425 Privet Road, Horsham, PA 19044. ANDA 070587............ Bupivacaine HCl Hospira, Inc. Injection USP, 0.75%. ANDA 070659............ Clonidine HCl Tablets, Teva Pharmaceuticals 0.3 mg. USA Inc., 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454. ANDA 070702............ Clonidine HCl Tablets, Do. 0.2 mg. ANDA 070747............ Clonidine HCl Tablets, Do. 0.1 mg. ANDA 070804............ Metaproterenol Sulfate Mylan Specialty, L.P., Inhalation Solution 781 Chestnut Ridge USP, 0.6%. Rd., P.O. Box 4310, Morgantown, WV 26504. ANDA 071067............ Methyldopa Tablets USP, Teva Pharmaceuticals 500 mg. USA, Inc. [[Page 28327]] ANDA 071101............ Clonidine HCl Tablets Duramed USP, 0.3 mg. Pharmaceuticals, Inc., 2 Quaker Rd., P.O. Box 2900, Pomona, NY 10970. ANDA 071102............ Clonidine HCl Tablets Do. USP, 0.2 mg. ANDA 071103............ Clonidine HCl Tablets Do. USP, 0.1 mg. ANDA 071105............ Methyldopa Tablets USP, Teva Pharmaceuticals 125 mg. USA, Inc. ANDA 071106............ Methyldopa Tablets USP, Do. 250 mg. ANDA 071426............ Vincasar PFS Teva Parenteral (vincristine sulfate) Medicines Inc., 19 Injection USP, 1 mg/mL. Hughes, Irvine, CA 92618. ANDA 071584............ Diazepam Injection USP, Hospira, Inc. 5 mg/mL. ANDA 071786............ Metaproterenol Sulfate Mylan Specialty L.P. Inhalation Solution USP, 0.4%. ANDA 072323............ Acetylcysteine Solution Roxane Laboratories, USP, 10%. Inc. ANDA 072324............ Acetylcysteine Solution Do. USP, 20%. ANDA 073034............ Metaproterenol Sulfate G&W Laboratories Inc., Oral Solution USP, 10 111 Coolidge St., mg/5 mL. South Plainfield, NJ 07080. ANDA 073636............ Dipivefrin HCl Alcon Pharmaceuticals, Ophthalmic Solution Ltd. USP, 0.1%. ANDA 073676............ Atenolol Tablets, 50 mg GD Searle LLC. and 100 mg. ANDA 074023............ Ranitidine Tablets USP, Mylan Pharmaceuticals 150 mg and 300 mg. Inc. ANDA 074160............ Bumetanide Injection Hospira, Inc. USP, 0.25 mg/mL. ANDA 074269............ Cimetidine in Sodium Do. Chloride 0.9% Injection USP, EQ6 mg base/mL). ANDA 074300............ Lorazepam Injection Do. USP, 2 mg/mL and 4 mg/ mL. ANDA 074396............ Enflurane Inhalation , Piramal Critical Care, 99.9%. Inc., 3950 Schelden Circle, Bethlehem, PA 18017. ANDA 074546............ Clozapine Tablets USP, Sandoz, Inc. 25 mg and 100 mg. ANDA 074632............ Atracurium Besylate Hospira, Inc. Injection, 10 mg/mL. ANDA 074851............ Levobunolol HCl Alcon Laboratories, Ophthalmic Solution Inc. USP, 0.25%. ANDA 074927............ Etodolac Tablets USP, Lehigh Valley 400 mg. Technologies, Inc., 514 North 12th St., Allentown, PA 18102. ANDA 075117............ Orapred (prednisolone Concordia sodium phosphate) Oral Pharmaceuticals, Solution, EQ 15 mg Inc., c/o Mapi USA, base/5 mL. Inc., 2343 Alexandria Dr., Suite 100, Lexington, KY 40504. ANDA 075436............ Paclitaxel Injection Accord Healthcare USP, 6 mg/mL. Inc., 1009 Slater Rd., Suite 210-B, Durham, NC 27703. ANDA 075721............ Leuprolide Acetate Genzyme Corp., 500 Injection, 1 mg/0.2 mL. Kendall St., Cambridge, MA 02142. ANDA 075963............ Tramadol HCl Tablets, Ivax Pharmaceuticals 50 mg. Inc. ANDA 076234............ Flavoxate HCl Tablets, Impax Laboratories, 100 mg. Inc., 30831 Huntwood Ave., Hayward, CA 94544. ANDA 076296............ Vincristine Sulfate Fresenius Kabi USA, Injection USP, 1 mg/mL. LLC. ANDA 076394............ Amiodarone HCl Par Sterile Products, Injection, 50 mg/mL. LLC, Morris Corporate Center 2, One Upper Pond Rd., Parsippany, NJ 07054. ANDA 076401............ Vincristine Sulfate Fresenius Kabi USA, Injection USP, 1 mg/mL. LLC. ANDA 076414............ Milrinone Lactate in 5% B. Braun Medical Inc. Dextrose Injection, EQ 20 mg base/100 mL. ANDA 076563............ Diltiazem HCl Extended- Nesher Pharmaceuticals Release Capsules USP, (USA) LLC, 13910 St. 120 mg, 180 mg, 240 Charles Rock Rd., mg, 300 mg, 360 mg, Bridgeton, MO 63044. 420 mg. ANDA 076699............ Parcopa (carbidopa and UCB, Inc., 1950 Lake levodopa) Orally Park Dr., Bldg. 2100, Disintegrating Smyrna, GA 30080. Tablets, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg. ANDA 077275............ Didanosine Tablets for Aurobindo Pharma Oral Suspension USP, Limited. 100 mg, 150 mg, and 200 mg. ANDA 077774............ Stavudine for Oral Do. Solution USP, 1 mg/mL. ANDA 077887............ Carvedilol Tablets USP, Hikma Pharmaceuticals, 3.125 mg, 6.25 mg, c/o West-Ward 12.5 mg, 25 mg. Pharmaceuticals Corp., 401 Industrial Way West, Eatontown, NJ 07724. ANDA 077968............ Alprazolam Extended- Impax Laboratories, Release Tablets, 0.5 Inc. mg, 1 mg, 2 mg, and 3 mg. ANDA 077996............ Alprazolam Extended- Do. Release Tablets, 0.5 mg, 1 mg, 2 mg, 3 mg. ANDA 078112............ Didanosine for Oral Aurobindo Pharma Solution USP, 10 mg/mL. Limited. ANDA 078240............ Carvedilol Tablets, Pliva Hrvatska d.o.o., 3.125 mg, 6.25 mg, Subsidiary of Teva 12.5 mg, and 25 mg. Pharmaceutical Industries Ltd., 425 Privet Rd., Horsham, PA 19044. ANDA 078254............ Atenolol Tablets USP, Northstar Healthcare 25 mg, 50 mg, and 100 Holdings, c/o Quality mg. Regulatory Consultants, 1966 Anglers Cove, Vero Beach, FL 32963. ANDA 078285............ Bicalutamide Tablets Roxane Laboratories, USP, 50 mg. Inc. ANDA 078298............ Sumatriptan Succinate Hikma Pharmaceuticals. Tablets USP, EQ 25 mg base, EQ 50 mg base, EQ 100 mg base. ANDA 078310............ Lamotrigine Tablets Pharmascience Inc., c/ USP, 25 mg, 100 mg, o Pharmascience 150 mg, and 200 mg. Laboratories Inc., 295 Firetower Rd., Tonawanda, NY 14150. ANDA 078334............ Granisol (granisetron PediatRx, Inc., c/o HCl Oral Solution, 2 Cardinal Health mg base/10mL. Regulatory Sciences, 7400 West 110th St., Commerce Plaza II, Suite 300, Overland Park, KS 66210. ANDA 078374............ Metoclopramide Tablets Northstar Healthcare USP, EQ 5 mg base and Holdings. EQ 10 mg base. ANDA 078408............ Vinorelbine Injection Sandoz Inc. USP, EQ 10 mg base/mL. [[Page 28328]] ANDA 078501............ Dronabinol Capsules Insys Therapeutics, USP, 2.5 mg, 5 mg, and Inc., 1333 South 10 mg. Spectrum Blvd., Suite 100, Chandler, AZ 85286. ANDA 078577............ Levofloxacin Injection, Hospira Inc. EQ 750 mg/30 mL and EQ 500 mg/20 mL. ANDA 078782............ Gabapentin Tablets USP, Hikma Pharmaceuticals. 600 mg and 800 mg. ANDA 078808............ Granisetron HCl Sandoz Inc. Injection USP, EQ 0.1 mg base/mL. ANDA 078812............ Oxaliplatin Injection Do. USP, 50 mg/10 mL and 100 mg/20 mL. ANDA 078952............ Glimepiride Tablets Hikma Pharmaceuticals. USP, 1 mg, 2 mg, and 4 mg. ANDA 079033............ Fomepizole Injection, Mylan Institutional 1.5 g/1.5 mL. LLC, 4901 Hiawatha Dr., Rockford, IL 61103. ANDA 080020............ Isopto Cetamide Alcon Laboratories, (sulfacetamide sodium) Inc. Ophthalmic Solution, 15%. ANDA 080021............ Sulfacetamide Sodium Do. Ophthalmic Ointment, 10%. ANDA 080229............ Naphcon Forte Do. (naphazoline HCl) Ophthalmic Solution USP 0.1%. ANDA 080248............ Albalon (naphazoline Allergan, Inc. HCl) Ophthalmic Solution USP, 0.1%. ANDA 080472............ Hytone (hydrocortisone) Valeant International Cream, 1% and 2.5%. (Barbados) SRL, c/o Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. ANDA 080473............ Hytone (hydrocortisone) Do. Lotion, 1% and 2.5%. ANDA 081043............ Prednisolone Sodium Alcon Pharmaceuticals, Phosphate Ophthalmic Ltd. Solution USP, EQ 0.11% phosphate. ANDA 081044............ Prednisolone Sodium Do. Phosphate Ophthalmic Solution USP, EQ 0.9% phosphate. ANDA 083205............ Orabase HCA Colgate-Palmolive Co., (hydrocortisone 909 River Rd., P.O. acetate) Topical Box 1343, Piscataway, Paste, 0.5%. NJ 08855-1343. ANDA 083342............ Maxidex (dexamethasone Alcon Laboratories, sodium phosphate) Inc. Ophthalmic Ointment, EQ 0.05% phosphate. ANDA 084645............ Chlordiazepoxide HCl Upsher-Smith Capsules USP, 25 mg. Laboratories, Inc. ANDA 084927............ Methocarbamol Tablets Impax Laboratories, USP, 500 mg. Inc. ANDA 084928............ Methocarbamol Tablets Do. USP, 750 mg. ANDA 085000............ Chlordiazepoxide HCl Hikma Pharmaceuticals. Capsules USP, 10 mg. ANDA 085014............ Chlordiazepoxide HCl Do. Capsules USP, 5 mg. ANDA 085095............ Statobex-G Teva Pharmaceuticals (phendimetrazine USA, Inc. tartrate) Tablets, 35 mg. ANDA 085294............ Chlordiazepoxide HCl Hikma Pharmaceuticals. Capsules USP, 25 mg. ANDA 085380............ Butisol Sodium Meda Pharmaceuticals (butabarbital sodium) Inc., 265 Davidson Oral Solution USP, 30 Ave., Suite #4300, mg/5 mL. Somerset, NJ 08873. ANDA 085734............ Ammonium Chloride B. Braun Medical Inc. Injection USP, 40 mEQ/ 100 mL. ANDA 085981............ Hydrocortisone Acetate X-Gen Pharmaceuticals, USP Micronized for Inc. Prescription Compounding, 100%. ANDA 085982............ Hydro-Rx Do. (hydrocortisone) USP Micronized for Prescription Compounding, 100%. ANDA 085995............ Pediatric LTA Kit Hospira, Inc. (lidocaine HCl) Topical Solution USP, 2%. ANDA 086535............ Acticort Baker Norton (hydrocortisone) Pharmaceuticals Inc., Lotion USP, 1%. 8800 N.W. 36 St., Miami, FL 33178-2404. ANDA 086911............ Phentermine HCl Teva Pharmaceuticals Capsules USP, 30 mg. USA, Inc. ANDA 087547............ Isopto Cetapred Alcon Laboratories, (sulfacetamide sodium Inc. and prednisolone acetate) Ophthalmic Ointment USP, 10%/ 0.25%. ANDA 087771............ Cetapred (sulfacetamide Do. sodium and prednisolone acetate) Ophthalmic Ointment USP, 10%/0.25%. ANDA 087907............ Epinephrine Inhalation Armstrong Aerosol USP, 0.2 mg/ Pharmaceuticals, inhalation). Inc., 25 John Rd., Canton MA 02021. ANDA 088613............ Phentermine HCl Teva Pharmaceuticals Capsules USP, 30 mg. USA, Inc. ANDA 088614............ Phentermine HCl Do. Capsules USP, 30 mg. ANDA 088630............ Pseudoephedrine HCl and Do. Triprolidine HCl Tablets, 60 mg/2.5 mg. ANDA 088631............ Butabarbital Sodium Do. Tablets, 30 mg. ANDA 088632............ Butabarbital Sodium Do. Tablets, 15 mg. ANDA 088797............ Phentermine HCl USL Pharma Inc., 301 Capsules USP, 30 mg. South Cherokee St., Denver, CO 80223 ANDA 088910............ Phentermine HCl Tablets Do. USP, 37.5 mg. ANDA 088917............ Phentermine HCl Tablets Do. USP, 37.5. ANDA 088999............ Dipyridamole Tablets Glenmark Generics USP, 25 mg. Limited, c/o Glenmark Generics Inc., USA, 750 Corporate Dr., Mahwah, NJ 07430. ANDA 089000............ Dipyridamole Tablets Do. USP, 50 mg. ANDA 089001............ Dipyridamole Tablets Do. USP, 75 mg. ANDA 089068............ Sulfacetamide Sodium Alcon Pharmaceuticals, Ophthalmic Solution, Ltd. 30%. ANDA 089172............ Tropicamide Ophthalmic Do. Solution, 1%. ANDA 089422............ Imipramine HCl Tablets Par Pharmaceutical USP, 10 mg. Inc., One Ram Ridge Rd., Spring Valley, NY 10977. ANDA 089440............ Hydrocortisone Acetate Vintage and Pramoxine HCl Pharmaceuticals, 150 Topical Aerosol, 1%/1%. Vintage Dr., Huntsville, AL 35811. [[Page 28329]] ANDA 089497............ Imipramine HCl Tablets Par Pharmaceutical USP, 25 mg. Inc. ANDA 089628............ Leucovorin Calcium for Pharmachemie USA Inc., Injection, EQ 50 mg 323 Davis St., base/vial. Northborough, MA 01532. ANDA 089681............ Bromfed-DM Wockhardt Bio AG, c/o (brompheniramine Morton Grove maleate, Pharmaceuticals, dextromethorphan Inc., 6451 Main St., hydrobromide, and Morton Grove, IL pseudoephedrine HCl) 60053. Syrup, 2 mg/5 mL; 10mg/ 5 mL; 30mg/5 mL. ANDA 089915............ Leucovorin Calcium for Pharmachemie USA Inc. Injection, EQ 100 mg base/vial. ANDA 090098............ Tretinoin Cream USP, Allergan Sales, LLC. 0.0375%. ANDA 090137............ Irinotecan HCl Sandoz Inc. Injection, 40 mg/2 mL and 100 mg/5 mL. ANDA 090190............ Pramipexole Do. Dihydrochloride Tablets, 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.5 mg. ANDA 090220............ Adenosine Injection Wockhardt Limited, c/o USP, 3 mg/mL. Wockhardt USA LLC, 20 Waterview Blvd., 3rd Floor, Parsippany, NJ 07054. ANDA 090300............ Children's Cetirizine Cypress HCl Allergy and Hives Pharmaceutical, Inc., Relief Oral Solution 10 North Park Place, OTC, 5 mg/5 mL. Suite 210, Morristown, NJ 07960. ANDA 090751............ Cetirizine HCl Oral Aurobindo Pharma Solution USP, 5 mg/5 Limited. mL. ANDA 090985............ Octreotide Acetate Wockhardt Limited. Preservative Free Injection EQ 0.05 mg base/mL, EQ 0.1 mg base/mL, and EQ 0.5 mg base/mL. ANDA 090986............ Octreotide Acetate Do. Injection EQ 0.2 mg base/mL and EQ 1 mg base/mL. ANDA 091068............ Ceftriaxone for Agila Specialties Injection USP, EQ 10 g Private Limited, c/o base/vial. Agila Specialties Inc., 201 South Main St., Suite 3, Lambertville, NJ 08530. ANDA 091185............ Topiramate Tablets USP, Hikma Pharmaceuticals. 25 mg, 50 mg, 100 mg, and 200 mg. ANDA 091293............ Idarubicin HCl Sandoz Inc. Injection, 1 mg/mL. ANDA 091299............ Fluorouracil Injection Do. USP, 2.5 g/50 mL and 5 g/100 mL. NDA 200045............. Amturnide (aliskiren Novartis hemifumarate, Pharmaceuticals Corp. amlodipine, andhydrochlorothiazide ) Tablets. ANDA 200146............ Doxorubicin HCl Sandoz Inc. Injection USP, 2 mg/mL. NDA 200199............. Topotecan Injection, EQ Do. 1 mg base/mL, EQ 3 mg base/3 mL, and EQ 4 mg base/4 mL. ANDA 201211............ Bromfenac Sodium Coastal Ophthalmic Solution, Pharmaceuticals, 1240 EQ 0.09% acid. Sugg Parkway, Greenville, NC 27834. NDA 201917............. Incivek (telaprevir) Vertex Tablets, 375 mg. Pharmaceuticals, Inc., 50 Northern Ave., Boston, MA 02210. NDA 202088............. Suprenza (phentermine Citius HCl) Orally Pharmaceuticals, LLC, Disintegrating 11 Commerce Dr., Tablets, 15 mg, 30 mg, First Floor, and 37.5 mg. Cranford, NJ 07016. ANDA 202209............ Tretinoin Cream USP, Allergan Sales, LLC. 0.075%. NDA 202513............. Gelnique (oxybutynin) Do. Gel, 3%. NDA 203595............. Suclear (magnesium Braintree sufate, polyethylene Laboratories, Inc. glycol 3350, potassium chloride, potassium sulfate, sodium bicarbonate, sodium chloride, and sodium sulfate) Oral Solution. NDA 204508............. Clinolipid 20% (olive Baxter Healthcare oil and soybean oil) Corp. USP, 16%/4%. NDA 206510............. Dutrebis (lamivudine Merck Sharp & Dohme and raltegravir Corp. potassium) Tablets, 150 mg/EQ 300 mg base. ------------------------------------------------------------------------ Therefore, under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in table 1 that are in inventory on the date that this notice becomes effective (see the DATES section) may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: June 15, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-12908 Filed 6-20-17; 8:45 am] BILLING CODE 4164-01-P
![28322 Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices
Drug Evaluation and Research, Food telephone to accessible at https://
and Drug Administration, 10903 New TuberculosisWorkshop2017@ www.regulations.gov. It may be viewed
Hampshire Ave., Bldg. 22, Rm. 6221, fda.hhs.gov. Early registration is at the Dockets Management Staff (see
Silver Spring, MD 20993–0002, 301– recommended because seating is ADDRESSES). A link to the transcript will
796–1300. limited; therefore, FDA may limit the also be available on the Internet at
SUPPLEMENTARY INFORMATION: number of participants from each http://www.fda.gov/Drugs/NewsEvents/
organization. Registrants will receive ucm548365.htm approximately 45 days
I. Background confirmation when they have been after the workshop.
FDA is announcing a public accepted. If time and space permit, Dated: June 15, 2017.
workshop regarding scientific and onsite registration on the day of the Anna K. Abram,
clinical trial design considerations for public workshop will be provided
Deputy Commissioner for Policy, Planning,
the development of new TB drug beginning at 7:30 a.m. We will let Legislation, and Analysis.
regimens. As such, discussions will registrants know if registration closes
[FR Doc. 2017–12906 Filed 6–20–17; 8:45 am]
focus on drug development programs before the day of the public workshop.
BILLING CODE 4164–01–P
and studies intended to evaluate shorter If you need special accommodations
and better tolerated TB drug regimens due to a disability, please contact Jessica
and new regimens that have efficacy for Barnes or Lori Benner (see FOR FURTHER
DEPARTMENT OF HEALTH AND
treatment of sensitive and drug-resistant INFORMATION CONTACT) no later than July
HUMAN SERVICES
TB. 14, 2017.
Requests for Oral Presentations: Food and Drug Administration
II. Topics for Discussion at the Public During online registration you may
Workshop indicate if you wish to present during a
public comment session and which [Docket No. FDA–2017–N–3203]
The FDA is conducting this workshop
to focus on scientific considerations topic(s) you wish to address. We will do Wyeth Pharmaceuticals Inc. et al.;
needed to advance the development of our best to accommodate requests to Withdrawal of Approval of 121 New
new TB treatment regimens. FDA is make public comments. Individuals and Drug Applications and 161 Abbreviated
particularly interested in discussing pre- organizations with common interests are New Drug Applications
clinical and clinical considerations urged to consolidate or coordinate their
relevant to the development of new TB presentations, and request time for a AGENCY: Food and Drug Administration,
treatment regimens. Discussions are joint presentation, or submit requests for HHS.
planned around the following topics: designated representatives to participate ACTION: Notice.
• Current landscape and challenges in the focused sessions. Following the
in TB drug development. close of registration, we will determine SUMMARY: The Food and Drug
• In vitro and in vivo nonclinical the amount of time allotted to each Administration (FDA) is withdrawing
models that may help select or deselect presenter and the approximate time approval of 121 new drug applications
new investigational TB drug regimens to each oral presentation is to begin, and (NDAs) and 161 abbreviated new drug
enter into clinical development. will select and notify participants by applications (ANDAs) from multiple
• Biomarkers that may help predict July 11, 2017. All requests to make oral applicants. The holders of the
responses to therapy at a time earlier presentations must be received by July applications notified the Agency in
than standard liquid or solid culture 10, 2017. If selected for presentation, writing that the drug products were no
results would allow. any presentation materials must be longer marketed and requested that the
• Surrogate endpoints that may be emailed to TuberculosisWorkshop2017@ approval of the applications be
used to predict clinical benefit. fda.hhs.gov no later than July 13, 2017. withdrawn.
• An update on TB diagnostics. No commercial or promotional material DATES: The withdrawal is effective on
• Options for assessing the will be permitted to be presented or July 21, 2017.
contribution of individual drugs in a distributed at the public workshop.
new TB treatment regimen. Streaming Webcast of the Public FOR FURTHER INFORMATION CONTACT:
• Clinical trial design challenges in Workshop: This public workshop will Florine P. Purdie, Center for Drug
pediatric and special populations. also be Webcast at the following site at Evaluation and Research, Food and
The Agency encourages health care https://collaboration.fda.gov/ Drug Administration, 10903 New
providers, other U.S. Government tbdd071917. Hampshire Ave., Bldg. 51, Rm. 6248,
Agencies, academic experts, industry, If you have never attended a Connect Silver Spring, MD 20993–0002, 301–
and other stakeholders to attend this Pro event before, please test your 796–3601.
public workshop. connection at https:// SUPPLEMENTARY INFORMATION: The
collaboration.fda.gov/common/help/en/ holders of the applications listed in
III. Participating in the Public support/meeting_test.htm. To get a table 1 in this document have informed
Workshop quick overview of the Connect Pro FDA that these drug products are no
Registration: Registration is free and program, visit https://www.adobe.com/ longer marketed and have requested that
based on space availability, with go/connectpro_overview. FDA has FDA withdraw approval of the
priority given to early registrants. verified the Web site addresses in this applications under the process in
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Persons interested in attending this document, as of the date this document § 314.150(c) (21 CFR 314.150(c)). The
public workshop must register by July publishes in the Federal Register, but applicants have also, by their requests,
14, 2017, midnight eastern standard Web sites are subject to change over waived their opportunity for a hearing.
time. To register, please provide time. Withdrawal of approval of an
complete contact information for each Transcripts: Please be advised that as application or abbreviated application
attendee, including name, title, soon as a transcript of the public under § 314.150(c) is without prejudice
affiliation, address, email, and workshop is available, it will be to refiling.
VerDate Sep<11>2014 19:12 Jun 20, 2017 Jkt 241001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\21JNN1.SGM 21JNN1](https://thefederalregister.org/doc/82_FR_28440/page/1.svg)
![Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices 28329
TABLE 1—Continued
Application No. Drug Applicant
ANDA 089497 .... Imipramine HCl Tablets USP, 25 mg ...................................... Par Pharmaceutical Inc.
ANDA 089628 .... Leucovorin Calcium for Injection, EQ 50 mg base/vial ........... Pharmachemie USA Inc., 323 Davis St., Northborough, MA
01532.
ANDA 089681 .... Bromfed-DM (brompheniramine maleate, dextromethorphan Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc.,
hydrobromide, and pseudoephedrine HCl) Syrup, 2 mg/5 6451 Main St., Morton Grove, IL 60053.
mL; 10mg/5 mL; 30mg/5 mL.
ANDA 089915 .... Leucovorin Calcium for Injection, EQ 100 mg base/vial ......... Pharmachemie USA Inc.
ANDA 090098 .... Tretinoin Cream USP, 0.0375% .............................................. Allergan Sales, LLC.
ANDA 090137 .... Irinotecan HCl Injection, 40 mg/2 mL and 100 mg/5 mL ........ Sandoz Inc.
ANDA 090190 .... Pramipexole Dihydrochloride Tablets, 0.125 mg, 0.25 mg, 0.5 Do.
mg, 0.75 mg, 1 mg, and 1.5 mg.
ANDA 090220 .... Adenosine Injection USP, 3 mg/mL ......................................... Wockhardt Limited, c/o Wockhardt USA LLC, 20 Waterview
Blvd., 3rd Floor, Parsippany, NJ 07054.
ANDA 090300 .... Children’s Cetirizine HCl Allergy and Hives Relief Oral Solu- Cypress Pharmaceutical, Inc., 10 North Park Place, Suite
tion OTC, 5 mg/5 mL. 210, Morristown, NJ 07960.
ANDA 090751 .... Cetirizine HCl Oral Solution USP, 5 mg/5 mL ......................... Aurobindo Pharma Limited.
ANDA 090985 .... Octreotide Acetate Preservative Free Injection EQ 0.05 mg Wockhardt Limited.
base/mL, EQ 0.1 mg base/mL, and EQ 0.5 mg base/mL.
ANDA 090986 .... Octreotide Acetate Injection EQ 0.2 mg base/mL and EQ 1 Do.
mg base/mL.
ANDA 091068 .... Ceftriaxone for Injection USP, EQ 10 g base/vial ................... Agila Specialties Private Limited, c/o Agila Specialties Inc.,
201 South Main St., Suite 3, Lambertville, NJ 08530.
ANDA 091185 .... Topiramate Tablets USP, 25 mg, 50 mg, 100 mg, and 200 Hikma Pharmaceuticals.
mg.
ANDA 091293 .... Idarubicin HCl Injection, 1 mg/mL ............................................ Sandoz Inc.
ANDA 091299 .... Fluorouracil Injection USP, 2.5 g/50 mL and 5 g/100 mL ....... Do.
NDA 200045 ...... Amturnide (aliskiren hemifumarate, amlodipine, Novartis Pharmaceuticals Corp.
andhydrochlorothiazide) Tablets.
ANDA 200146 .... Doxorubicin HCl Injection USP, 2 mg/mL ................................ Sandoz Inc.
NDA 200199 ...... Topotecan Injection, EQ 1 mg base/mL, EQ 3 mg base/3 Do.
mL, and EQ 4 mg base/4 mL.
ANDA 201211 .... Bromfenac Sodium Ophthalmic Solution, EQ 0.09% acid ...... Coastal Pharmaceuticals, 1240 Sugg Parkway, Greenville,
NC 27834.
NDA 201917 ...... Incivek (telaprevir) Tablets, 375 mg ........................................ Vertex Pharmaceuticals, Inc., 50 Northern Ave., Boston, MA
02210.
NDA 202088 ...... Suprenza (phentermine HCl) Orally Disintegrating Tablets, 15 Citius Pharmaceuticals, LLC, 11 Commerce Dr., First Floor,
mg, 30 mg, and 37.5 mg. Cranford, NJ 07016.
ANDA 202209 .... Tretinoin Cream USP, 0.075% ................................................ Allergan Sales, LLC.
NDA 202513 ...... Gelnique (oxybutynin) Gel, 3% ................................................ Do.
NDA 203595 ...... Suclear (magnesium sufate, polyethylene glycol 3350, potas- Braintree Laboratories, Inc.
sium chloride, potassium sulfate, sodium bicarbonate, so-
dium chloride, and sodium sulfate) Oral Solution.
NDA 204508 ...... Clinolipid 20% (olive oil and soybean oil) USP, 16%/4% ........ Baxter Healthcare Corp.
NDA 206510 ...... Dutrebis (lamivudine and raltegravir potassium) Tablets, 150 Merck Sharp & Dohme Corp.
mg/EQ 300 mg base.
Therefore, under authority delegated Dated: June 15, 2017. ACTION: Notice of award of a single-
to the Director, Center for Drug Anna K. Abram, source unsolicited grant to Washington
Evaluation and Research, by the Deputy Commissioner for Policy, Planning, University in St. Louis, Missouri.
Commissioner, approval of the Legislation, and Analysis.
applications listed in table 1, and all SUMMARY: The Office of Research
[FR Doc. 2017–12908 Filed 6–20–17; 8:45 am]
amendments and supplements thereto, Integrity (ORI) announces the award of
BILLING CODE 4164–01–P
is hereby withdrawn. Introduction or a single-source, grant in response to an
delivery for introduction into interstate unsolicited proposal from Washington
University, St. Louis, Missouri. The
commerce of products without DEPARTMENT OF HEALTH AND proposal submitted was not solicited
approved new drug applications HUMAN SERVICES either formally or informally by any
violates section 301(a) and (d) of the
federal government official.
Federal Food, Drug, and Cosmetic Act [CFDA Number: 93.085]
(21 U.S.C. 331(a) and (d)). Drug FOR FURTHER INFORMATION CONTACT:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
products that are listed in table 1 that Kathryn Partin at kathryn.partin@
Awards Unsolicited Proposal for the
are in inventory on the date that this hhs.gov or by telephone at 240–453–
Professionalism and Integrity in
notice becomes effective (see the DATES 8200.
Research Program
section) may continue to be dispensed SUPPLEMENTARY INFORMATION:
until the inventories have been depleted AGENCY: Office of Research Integrity, Recipient: Washington University, St.
or the drug products have reached their Office of the Assistant Secretary for Louis, Missouri.
expiration dates or otherwise become Health, Department of Health and Purpose of the Award: Grant to
violative, whichever occurs first. Human Services. provide remediation training through
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Document Created: 2018-11-14 10:09:23
Document Modified: 2018-11-14 10:09:23
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The withdrawal is effective on July 21, 2017. | |
| Contact | Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601. | |
| FR Citation | 82 FR 28322 |
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