81 FR 68427 - Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 192 (October 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 192 (October 4, 2016)
| Page Range | 68427-68432 | |
| FR Document | 2016-23893 |
[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)] [Notices] [Pages 68427-68432] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-23893] [[Page 68427]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0002] Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 44 new drug applications (NDAs) and 158 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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: Effective Date: November 3, 2016. 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. Table 1 ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ NDA 005264............. Heparin Sodium Hospira, Inc., 275 Injection. North Field Dr., Bldg. H2-2, Lake Forest, IL 60045- 5046. NDA 009470............. Xylocaine Viscous Fresenius Kabi USA (lidocaine LLC, Three Corporate hydrochloride (HCl)) Dr., Lake Zurich, IL Solution. 60047. NDA 009698............. Miltown (meprobamate) Meda Pharmaceuticals, Tablets, 200 Inc., 265 Davidson milligrams (mg) and Ave., Suite 300, 400 mg. Somerset, NJ 08873- 4120. NDA 009939............. Senokot Granules Purdue Products, L.P., (sennosides), 15 mg. One Stamford Forum, Stamford, CT 06901. NDA 010382............. Tempra (acetaminophen) Bristol-Myers Squibb Syrup, 160 mg/5 Co., P.O. Box 4000, milliliters (mL). Princeton, NJ 88543- 4000. NDA 011228............. Liquamar Organon USA Inc., (phenprocoumon) Subsidiary of Merck & Tablets. Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033. NDA 011613............. Ionamin (phentermine UCB, Inc., 1950 Lake resin complex) Park Dr., Smyrna, GA Capsules, 15 mg and 30 30080. mg. NDA 011738............. Numorphan (oxymorphone Endo Pharmaceuticals, HCl) Suppositories, 5 Inc., 100 Endo Blvd., mg. Chadds Ford, PA 19317. NDA 012365............. Soma Compound Meda Pharmaceuticals, (carisoprodol and Inc. aspirin) Tablets. NDA 012940............. Isordil (isosorbide Valeant International dinitrate) Sublingual Bermuda, c/o Valeant Tablets, 2.5 mg, 5 mg, Pharmaceuticals North and 10 mg. America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. NDA 013483............. Drixoral/Disophrol Merck Consumer Care, (dexbrompheniramine 556 Morris, Ave., maleate and Summit, NJ 07901. pseudoephedrine sulfate) Extended- Release Tablets, 6 mg/ 120 mg. NDA 014005............. Maxibolin Organon USA Inc. (ethylestrenol) Tablets. NDA 017087............. Ethrane (enflurane USP) Baxter Healthcare Corp., 32650 N. Wilson Rd., Round Lake, IL 60073. NDA 017689............. Methadone HCl Syrup.... Sandoz, Inc., 4700 Sandoz, Dr., Wilson, NC 27893. NDA 018766............. Ansaid (flurbiprofen) Pharmacia & Upjohn Tablets, 50 mg and 100 Co., c/o Pfizer, mg. Inc., 235 East 42nd St., New York, NY 10017. NDA 018812............. Sulfamethoxazole and Teva Pharmaceuticals Trimethoprim Oral USA, Inc., 1090 Suspension USP, 200 mg/ Horsham Rd., P.O. Box 5 mL and 40 mg/5 mL. 1090, North Wales, PA 19454. NDA 019304............. Tricor (fenofibrate) AbbVie Inc., 1 N. Micronized Capsules, Waukegan Rd., Dept. 67 mg, 134 mg, and 200 PA77/Bldg. AP30, mg. North Chicago, IL 60064. NDA 019384............. Noroxin (norfloxacin) Merck Sharp & Dohme Tablets, 400 mg. Corp., 351 North Sumneytown Pike, P.O. Box 1000, North Wales, PA 19454. NDA 020005............. Cardene SR (nicardipine Chiesi USA, Inc., 1255 HCl) Extended-Release Crescent Green Dr., Capsules, 30 mg, 45 Suite 250, Cary, NC mg, and 60 mg. 27518. NDA 020073............. Romazicon (flumazenil) Hoffman-LaRoche, Inc., Injection. c/o Genetech, Inc., 1 DNA Way MS #241B, South San Francisco, CA 94080-4900. NDA 020084............. Iobenguane Sulfate I- Pharmalucence, 10 131 Injection, 2.3 DeAngelo Dr., millicuries. Bedford, MA 01730. NDA 020107............. Novamine (amino acids) Baxter Healthcare Injection. Corp. NDA 020229............. Leustatin (cladribine) Janssen Injection, 1 mg/mL. Pharmaceuticals Inc., 920 Route 202 South, P.O. Box 300, Raritan, NJ 08869- 0602. NDA 020251............. Zantac (ranitidine HCl) Glaxo Group Limited, Effervescent Tablets, England d/b/a 25 mg and 150 mg GlaxoSmithKline, Five Zantac (ranitidine Moore Dr., P.O. Box HCl) Effervescent 13398, Research Granules, 150 mg. Triangle Park, NC 27709. NDA 020312............. Univasc (moexipril HCl) UCB, Inc. Tablets, 7.5 mg and 15 mg. NDA 020346............. Zyrtec (cetirizine HCl) Johnson and Johnson Syrup, 1 mg/mL. Consumer Inc., McNeil Consumer Healthcare Division, 7050 Camp Hill Rd., Fort Washington, PA 19034- 2299. NDA 020410............. Gastromark (ferumoxsil) AMAG Pharmaceuticals, Oral Suspension. 100 Haydon Ave., Lexington, MA 02421. [[Page 68428]] NDA 020416............. Feridex I.V. Do. (ferumoxides) Injection. NDA 020460............. Cytovene (ganciclovir) Roche Palo Alto LLC, c/ Capsules, 250 mg and o Genentech, Inc., 1 500 mg. DNA Way, MS#241B, South San Francisco, CA 94080-4990. NDA 020575............. DentiPatch (lidocaine). Noven Pharmaceuticals, Inc., 11960 SW. 144th St., Miami, FL 33186. NDA 020638............. Vistide (cidofovir) Gilead Sciences, Inc., Injection, Equivalent 333 Lakeside Dr., to (EQ) 75 mg base/mL. Foster City, CA 94404. NDA 020729............. Uniretic (moexipril HCl UCB, Inc. and hydrochlorothiazide) Tablets, 7.5 mg/12.5 mg, 15 mg/12.5 mg, and 15 mg/25 mg. NDA 021044............. Palladone Rhodes Pharmaceuticals (hydromorphone HCl) L.P., 498 Washington Extended-Release St., Coventry, RI Capsules. 02816. NDA 021046............. Celexa (citalopram Forest Laboratories, hydrobromide) EQ 10 mg Inc., Harborside base/5 mL Oral Financial Center, Solution. Plaza V, Suite 1900, Jersey, City, NJ 07311. NDA 021378............. Combunox (Oxycodone HCl Do. and Ibuprofen) Tablets. NDA 021671............. DepoDur (morphine Pacira sulfate) Extended- Pharmaceuticals, Release Injection. Inc., 10450 Science Center Dr., San Diego, CA 92121. NDA 021693............. Rybix ODT (tramadol Shionogi, Inc., 300 HCl) Orally Campus Dr., Suite Disintegrating Tablets. 300, Florham Park, NJ 07932. NDA 021768............. Fludeoxyglucose F18 Weill Medical College (FDG) Injection. of Cornell University, c/o Citigroup Biomedical Imaging Center, 516 East 72nd St., New York, NY 10021. NDA 022244............. Lusedra (fospropofol Eisai, Inc., 155 Tice disodium) Injection. Blvd., Woodcliff Lake, NJ 07677. NDA 022312............. Docetaxel Injection.... Apotex Inc., c/o Apotex Corp., 2400 North Commerce Parkway, Suite 400, Weston, FL 33326. ANDA 040223............ Acetaminophen and Barr Laboratories, Codeine Phosphate Inc., Subsidiary of Tablets USP, 300 mg/15 Teva Pharmaceuticals mg, 300 mg/30 mg, and USA, Inc., 425 Privet 300 mg/60 mg. Rd., Horsham, PA 19044. ANDA 040297............ Estradiol Tablets USP, Upsher-Smith 0.5 mg, 1 mg, and 2 mg. Laboratories, Inc., 6701 Evenstad Dr., Maple Grove, MN 55369. ANDA 040311............ Medroxyprogesterone Duramed Acetate Tablets USP, Pharmaceuticals, 2.5 mg, 5 mg, and 10 Inc., Subsidiary of mg. Teva Pharmaceuticals USA Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 040318............ Meperidine HCl Tablets Do. USP, 50 mg and 100 mg. ANDA 040472............ Dextroamphetamine Teva Pharmaceuticals Saccharate, USA, Inc., 425 Privet Amphetamine Aspartate, Rd., Horsham, PA Dextroamphetamine 19044. Sulfate, and Amphetamine Sulfate Tablets. NDA 050143............. Chloromycetin Parkedale (chloramphenicol Pharmaceuticals, ophthalmic solution Inc., c/o King USP) Ophthalmic Pharmaceuticals, Solution. Inc., 501 Fifth St., Bristol, TN 37620. NDA 050156............. Chloromycetin Do. (chloramphenicol ophthalmic ointment USP) Ophthalmic Ointment, 1%. NDA 050443............. Blenoxane (bleomycin Bristol-Myers Squibb sulfate) for Co. Injection, EQ 15 units base/vial and 30 units base/vial. NDA 050630............. Primaxin (imipenem and Merck, Sharp & Dohme cilastatin sodium) Corp. Powder, EQ 500 mg base/ vial; 500 mg/vial and EQ 750 mg base/vial; 750 mg/vial. ANDA 060306............ Penicillin G Potassium Teva Pharmaceuticals Tablets USP. USA, Inc. ANDA 060307............ Penicillin G Potassium Do. for Oral Solution USP. ANDA 061969............ Cephalexin Capsules Ivax Pharmaceuticals, USP, EQ 250 mg base Inc., Subsidiary of and EQ 500 mg base. Teva Pharmaceuticals USA, Inc. ANDA 062240............ Cloxacillin Sodium Teva Pharmaceuticals Capsules USP, EQ 250 USA, Inc. mg base and EQ 500 mg base. ANDA 062252............ Oxacillin Sodium for Teva Pharmaceuticals Oral Solution USP, EQ USA, Inc. 250 mg base/5 mL. ANDA 062268............ Cloxacillin Sodium for Do. Oral Solution USP, EQ 125 mg base/5 mL. ANDA 062653............ Doryx (doxycycline Warner Chilcott Co., hyclate) Delayed- LLC, c/o Warner Release Capsules, EQ Chilcott (US), LLC, 100 mg base. 100 Enterprise Dr., Rockaway, NJ 07866. ANDA 062670............ Nystatin Oral Teva Pharmaceuticals Suspension USP, USA, Inc. 100,000 units/mL. ANDA 062683............ Cephradine Capsules Do. USP, 250 mg and 500 mg. ANDA 062695............ Cefadroxil Capsules Do. USP, EQ 500 mg base. ANDA 062751............ Erythromycin Pledgets Ivax Pharmaceuticals, USP, 2%. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 062760............ Cephalexin Capsules Teva Pharmaceuticals USP, EQ 250 mg base. USA, Inc. ANDA 062761............ Cephalexin Capsules Do. USP, EQ 500 mg base. ANDA 062766............ Cefadroxil Capsules Ivax Pharmaceuticals, USP, EQ 500 mg base. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 062767............ Cephalexin for Oral Teva Pharmaceuticals Suspension USP, EQ 125 USA, Inc. mg base/5 mL. ANDA 062768............ Cephalexin for Oral Do. Suspension USP, EQ 250 mg base/5 mL. ANDA 062775............ Cephalexin Capsules Barr Laboratories, USP, EQ 500 mg base. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 062853............ Amoxicillin Capsules Teva Pharmaceuticals USP, 250 mg. USA, Inc. ANDA 062854............ Amoxicillin Capsules Do. USP, 500 mg. ANDA 062946............ Amoxicillin for Oral Do. Suspension USP, 125 mg/ 5 mL. ANDA 063001............ Amoxicillin for Oral Do. Suspension USP, 250 mg/ 5 mL. [[Page 68429]] ANDA 063018............ Cefazolin Sodium for Do. Injection USP, EQ 5 grams (g) base/vial and EQ 10 g base/vial. ANDA 063027............ Clindamycin HCl Do. Capsules USP, EQ 75 mg base. ANDA 063030............ Amoxicillin Capsules Do. USP, 250 mg. ANDA 063031............ Amoxicillin Capsules Do. USP, 500 mg. ANDA 064031............ Amoxicillin Chewable Do. Tablets, 125 mg and 250 mg. ANDA 064081............ Cefaclor Capsules USP, Do. EQ 250 mg base and EQ 500 mg base. ANDA 064145............ Cefaclor Capsules USP, Do. EQ 250 mg base and EQ 500 mg base. ANDA 065137............ Clarithromycin Tablets Ivax Pharmaceuticals, USP, 250 mg and 500 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 070006............ Sulfamethoxazole and Mutual Pharmaceutical Trimethoprim Tablets Co., Inc., 1100 USP, 400 mg/80 mg. Orthodox St., Philadelphia, PA 19124. ANDA 070007............ Sulfamethoxazole and Do. Trimethoprim Tablets USP, 800 mg/160 mg. ANDA 070232............ Propranolol HCl Tablets Teva Pharmaceuticals USP, 10 mg. USA, Inc. ANDA 070234............ Propranolol HCl Tablets Do. USP, 40 mg. ANDA 070266............ Indo-Lemmon Do. (Indomethacin Capsules USP), 25 mg. ANDA 070267............ Indo-Lemmon Do. (Indomethacin Capsules USP), 50 mg. ANDA 070469............ Ibuprohn (Ibuprofen Ohm Laboratories, Tablets USP), 400 mg. Inc., c/o Ranbaxy Inc., 600 College Rd. East, Princeton, NJ 08540. ANDA 070618............ Potassium Chloride Copley Pharmaceutical, Extended-Release Inc., Subsidiary of Tablets USP, 8 Teva Pharmaceuticals milliequivalents. USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 070660............ Metoclopramide HCl Mutual Pharmaceutical Tablets USP, EQ 10 mg Co., Inc. base. ANDA 071145............ Ibuprofen Tablets USP.. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 071146............ Ibuprofen Tablets USP, Do. 600 mg. ANDA 071184............ Thiothixene HCl Oral Teva Pharmaceuticals Solution USP, EQ 5 mg USA, Inc. base/mL. ANDA 071342............ Indomethacin Capsules Do. USP, 25 mg. ANDA 071343............ Indomethacin Capsules Do. USP, 50 mg. ANDA 072438............ Fenoprofen Calcium Par Pharmaceutical, Capsules USP, EQ 300 Inc., One Ram Ridge mg base. Rd., Spring Valley, NY 10977. ANDA 072522............ Fluocinonide Topical Teva Pharmaceuticals Solution USP, 0.05%. USA, Inc. ANDA 072600............ Clofibrate Capsules Do. USP, 500 mg. ANDA 072692............ Norethindrone and Barr Laboratories, Ethinyl Estradiol Inc., Subsidiary of Tablets USP, 0.5 mg/ Teva Pharmaceuticals, 0.035 mg. USA, Inc. ANDA 072999............ Dopamine HCl Injection Teva Parenteral USP, 200 mg/5 mL. Medicines, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 073005............ Cinoxacin Capsules USP, Teva Pharmaceuticals 250 mg. USA, Inc. ANDA 073006............ Cinoxacin Capsules USP, Do. 500 mg. ANDA 073043............ Baclofen Tablets USP, Do. 10 mg. ANDA 073044............ Baclofen Tablets USP, Do. 20 mg. ANDA 073099............ Leucovorin Calcium Pharmachemie B.V., Tablets USP, EQ 5 mg Subsidiary of Teva base. Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 073101............ Leucovorin Calcium Do. Tablets USP, EQ 25 mg base. ANDA 073141............ Ibuprofen Tablets USP, Teva Pharmaceuticals 200 mg. USA, Inc. ANDA 073315............ Atenolol Tablets USP, Do. 50 mg. ANDA 073316............ Atenolol Tablets USP, Do. 100 mg. ANDA 073343............ Ibuprofen Tablets USP, Do. 400 mg. ANDA 073344............ Ibuprofen Tablets USP, Do. 600 mg. ANDA 073345............ Ibuprofen Tablets USP, Do. 800 mg. ANDA 073515............ Ketoprofen Capsules Do. USP, 25 mg. ANDA 073679............ Diflunisal Tablets USP, Do. 250 mg. ANDA 074067............ Diltiazem HCl Tablets Do. USP, 30 mg, 60 mg, 90 mg, and 120 mg. ANDA 074107............ Atenolol and Pliva, Inc., Chlorthalidone Tablets Subsidiary of Teva USP, 50 mg/25 mg and Pharmaceuticals USA, 100 mg/25 mg. Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 074120............ Atenolol Tablets USP, Teva Pharmaceuticals 50 mg and 100 mg. USA, Inc. ANDA 074123............ Pindolol Tablets USP, 5 G&W Laboratories, mg and 10 mg. Inc., 111 Coolidge St., South Plainfield, NJ 07080. ANDA 074124............ Ciprofloxacin HCl Barr Laboratories, Tablets, EQ 250 mg Inc., Subsidiary of base, EQ 500 mg base, Teva Pharmaceuticals and EQ 750 mg base. USA, Inc. ANDA 074143............ Metoprolol Tartrate Teva Pharmaceuticals Tablets USP, 50 mg and USA, Inc. 100 mg. ANDA 074216............ Naproxen Tablets, 250 Do. mg, 375 mg, and 500 mg. ANDA 074294............ Alprazolam Tablets USP, Ivax Pharmaceuticals, 0.25 mg, 0.5 mg, 1 mg, Inc., Subsidiary of and 2 mg. Teva Pharmaceuticals USA, Inc. ANDA 074333............ Metoprolol Tartrate Teva Pharmaceuticals Tablets USP, 50 mg and USA, Inc. 100 mg. ANDA 074357............ Trazodone HCl Tablets Do. USP, 150 mg. ANDA 074365............ Cimetidine Tablets USP, Do. 200 mg, 300 mg, 400 mg, and 800 mg. [[Page 68430]] ANDA 074446............ Terazosin HCl Tablets, Do. EQ 1 mg base, EQ 2 mg base, EQ 5 mg base, and EQ 10 mg base. ANDA 074459............ Diclofenac Sodium Do. Delayed-Release Tablets USP, 25 mg, 50 mg, and 75 mg. ANDA 074476............ Hydroxyurea Capsules Roxane Laboratories, USP, 500 mg. Inc., 1809 Wilson Rd., Columbus, OH 43228. ANDA 074504............ Tamoxifen Citrate Teva Pharmaceuticals Tablets USP, EQ 10 mg USA, Inc. base and EQ 20 mg base. ANDA 074537............ Selegiline HCl Tablets G&W Laboratories, Inc. USP, 5 mg. ANDA 074555............ Cholestyramine for Oral Teva Pharmaceuticals, Suspension USP. USA, Inc. ANDA 074674............ Acyclovir Capsules USP, Ivax Pharmaceuticals, 200 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 074745............ Megestrol Acetate Teva Pharmaceuticals Tablets USP, 40 mg. USA, Inc. ANDA 074771............ Cholestyramine for Oral Do. Suspension USP. ANDA 074847............ Etodolac Tablets USP, Do. 400 mg and 500 mg. ANDA 074883............ Etodolac Tablets USP, Ivax Pharmaceuticals, 400 mg and 500 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 074895............ Amiodarone HCl Tablets, Teva Pharmaceuticals 200 mg. USA, Inc. ANDA 074914............ Acyclovir Capsules USP, Do. 200 mg. ANDA 074989............ Labetalol HCl Tablets Do. USP, 100 mg, 200 mg, and 300 mg. ANDA 075021............ Acyclovir Tablets USP, Do. 400 mg and 800 mg. ANDA 075557............ Ranitidine HCl Do. Capsules, EQ 150 mg base and EQ 300 mg base. ANDA 075686............ Bisoprolol Fumarate and Do. Hydrochlorothiazide Tablets USP, 2.5 mg/ 6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg. ANDA 075719............ Sertraline HCl Tablets Do. USP, EQ 25 mg base, EQ 50 mg base, and EQ 100 mg base. ANDA 075726............ Pemoline Tablets, 18.75 Mallinckrodt Inc., 675 mg, 37.5 mg, and 75 mg. McConnell Blvd., Hazelwood, MO 63042. ANDA 075740............ Tamoxifen Citrate Ivax Pharmaceuticals, Tablets USP, EQ 10 mg Inc., Subsidiary of base and EQ 20 mg base. Teva Pharmaceuticals USA, Inc. ANDA 075810............ Fluoxetine HCl Tablets Barr Laboratories, , EQ 10 mg base. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 075823............ Calcitriol Injection Teva Parenteral USP, 0.001 mg/mL and Medicines, Inc. 0.002 mg/mL. ANDA 075827............ Gabapentin Tablets USP, Teva Pharmaceuticals 600 mg and 800 mg. USA, Inc. ANDA 075862............ Levonorgestrel and Barr Laboratories, Ethinyl Estradiol Inc., Subsidiary of Tablets USP, 0.1 mg/ Teva Pharmaceuticals 0.02 mg. USA, Inc. ANDA 075865............ Fluoxetine HCl Tablets Ivax Pharmaceuticals, , EQ 10 mg base and EQ Inc., Subsidiary of 40 mg base. Teva Pharmaceuticals USA, Inc. ANDA 075971............ Metformin HCl Tablets Barr Laboratories, USP, 500 mg, 850 mg, Inc., Subsidiary of and 1 g. Teva Pharmaceuticals USA, Inc. ANDA 075975............ Metformin HCl Tablets Ivax Pharmaceuticals, USP, 500 mg, 625 mg, Inc., Subsidiary of 750 mg, 850 mg, and 1 Teva Pharmaceuticals g. USA, Inc. ANDA 076094............ Pergolide Mesylate Do. Tablets, EQ 0.05 mg base, EQ 0.25 mg base, and EQ 1 mg base. ANDA 076184............ Alendronate Sodium Teva Pharmaceuticals Tablets USP, EQ 35 mg USA, Inc. tablets and EQ 70 mg tablets. ANDA 076198............ Balziva-21 Tablets Barr Laboratories, (norethindrone and Inc., Subsidiary of ethinyl estradiol Teva Pharmaceuticals tablets USP), 0.4 mg/ USA, Inc. 0.035 mg. ANDA 076244............ Mirtazapine Tablets Ivax Pharmaceuticals, USP, 15 mg, 30 mg, and Inc., Subsidiary of 45 mg. Teva Pharmaceuticals USA, Inc. ANDA 076251............ Fluoxetine HCl Barr Laboratories, Capsules, EQ 40 mg Inc., Subsidiary of base. Teva Pharmaceuticals USA, Inc. ANDA 076328............ Metformin HCl Tablets Teva Pharmaceuticals USP, 500 mg, 850 mg, USA, Inc. and 1 g. ANDA 076340............ Finasteride Tablets Ivax Pharmaceuticals, USP, 5 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 076426............ Ciprofloxacin HCl Pliva, Inc., Tablets , EQ 100 mg Subsidiary of Teva base, EQ 250 mg base, Pharmaceuticals USA, EQ 500 mg base, and EQ Inc. 750 mg base. ANDA 076496............ Metformin HCl Extended- Barr Pharmaceuticals, Release Tablets USP, Inc., Subsidiary of 500 mg. Teva Pharmaceuticals USA, Inc. ANDA 076545............ Metformin HCl Extended- Ivax Pharmaceuticals, Release Tablets USP, Inc., Subsidiary of 500 mg. Teva Pharmaceuticals USA, Inc. ANDA 076840............ Sumatriptan Succinate Teva Pharmaceuticals Tablets, EQ 25 mg USA, Inc. base, EQ 50 mg base, and EQ 100 mg base. ANDA 076880............ Nicotine Polacrilex Gum Ivax Pharmaceuticals, USP, EQ 2 mg base. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 076945............ Fosinopril Sodium and Teva Pharmaceuticals Hydrochlorothiazide USA, Inc. Tablets USP, 10 mg/ 12.5 mg and 20 mg/12.5 mg. ANDA 077020............ Cilostazol Tablets USP, Ivax Pharmaceuticals, 100 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 077082............ Paroxetine Tablets USP, Teva Pharmaceuticals EQ 10 mg base, EQ 20 USA, Inc. mg base, EQ 30 mg base, and EQ 40 mg base. [[Page 68431]] ANDA 077775............ Fentanyl Extended- Noven, Release Film, 25 Pharmaceuticals, Inc. micrograms (mcg), 50 mcg, 75 mcg, and 100 mcg. ANDA 077850............ Nicotine Polacrilex Gum Ivax Pharmaceuticals, USP, EQ 4 mg base. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 077898............ Cilostazol Tablets USP, Pliva Hrvatska DOO, c/ 50 mg and 100 mg. o Teva Pharmaceuticals USA, Inc.,425 Privet Rd., Horsham, PA 19044. ANDA 077973............ Bicalutamide Tablets Synthon USP, 50 mg. Pharmaceuticals, Inc., 9000 Development Dr., P.O. Box 110487, Research Triangle Park, NC 27709. ANDA 077995............ Bicalutamide Tablets Kudco Ireland Limited, UPS, 50 mg. c/o Kremers Urban Pharmaceuticals, Inc., 1101 C Ave. West, Seymour, IN 47274. ANDA 078079............ Ciclopirox Topical Teva Pharmaceuticals Solution USP, 8%. USA, Inc. ANDA 078221............ Granisetron HCl Tablets Barr Laboratories, USP, EQ 1 mg base. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 078263............ Perindopril Erbumine Lupin Limited, c/o Tablets, 2 mg, 4 mg, Lupin and 8 mg. Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 21st Floor, Baltimore, MD 21202. ANDA 078567............ Ciclopirox Topical Mylan Pharmaceuticals Solution USP, 8%. Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504. ANDA 078666............ Levonorgestrel Tablets, Watson Laboratories, 0.75 mg. Inc., 311 Bonnie Circle, Corona, CA 92880. ANDA 078773............ Atorvastatin Calcium Teva Pharmaceuticals Tablets, EQ 10 mg USA, Inc. base, EQ 20 mg (base), EQ 40 mg base, and EQ 80 mg base. ANDA 080400............ Hydrocortisone Cream Do. USP. ANDA 080828............ Hydrocortisone Acetate Fera Pharmaceuticals Ophthalmic Ointment LLC, 134 Birch Hill USP, 0.5%. Rd., Locust Valley, NY 11560. ANDA 083919............ Meprobamate Tablets Meda Pharmaceuticals USP, 600 mg. Inc., 265 Davidson Ave., Suite 400, Somerset, NJ 08873. ANDA 085022............ Hydrochlorothiazide Ivax Pharmaceuticals, Tablets USP, 100 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 085855............ A-Methapred Hospira, Inc. (methylprednisolone sodium succinate for Injection USP), EQ 125 mg base/vial. ANDA 086750............ Ergotamine Tartrate Organon USA, Inc. Sublingual Tablets USP, 2 mg. ANDA 087014............ Orgatrax (hydroxyzine Do. HCl Injection USP), 25 mg/mL and 50 mg/mL. ANDA 087264............ Thioridazine HCl Mutual Pharmaceutical Tablets USP, 25 mg. Co., Inc. ANDA 087665............ Sulfinpyrazone Tablets Barr Pharmaceuticals, USP, 100 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 087666............ Sulfinpyrazone Capsules Do. USP, 200 mg. ANDA 087760............ Hydroxyzine Pamoate Ivax Pharmaceuticals, Capsules USP, EQ 50 mg Inc., Subsidiary of HCl. Teva Pharmaceuticals USA, Inc. ANDA 087761............ Hydroxyzine Pamoate Do. Capsules USP, EQ 25 mg HCl. ANDA 088370............ Thioridazine HCl Mutual Pharmaceutical Tablets USP, 50 mg. Co., Inc. ANDA 088375............ Thioridazine HCl Do. Tablets USP, 10 mg. ANDA 088379............ Thioridazine HCl Do. Tablets USP, 100 mg. ANDA 088469............ Dexamethasone Sodium Fresenius Kabi USA, Phosphate Injection LLC. USP, EQ 10 mg Phosphate/mL. ANDA 088900............ Doxylamine Succinate Copley Tablets USP, 25 mg. Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 088902............ Chlorthalidone Tablets Barr Laboratories, USP, 25 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 088903............ Chlorthalidone Tablets Do. USP, 50 mg. ANDA 088974............ Procainamide HCl ANI Pharmaceuticals, Extended-Release Inc.,. Tablets USP, 500 mg. ANDA 089109............ Promethazine HCl Teva Pharmaceuticals Tablets USP, 25 mg. USA, Inc. ANDA 090299............ Melphalan HCl for Mylan Institutional Injection, EQ 50 mg LLC, 4901 Hiawatha base/vial. Dr., Rockford, IL 61103. ANDA 090924............ Ibutilide Fumarate Do. Injection, 0.1 mg/mL. ANDA 091242............ Anastrozole Tablets Impax Laboratories, USP, 1 mg. Inc., 30831 Huntwood Ave., Hayward, CA 94544. ANDA 091638............ Letrozole Tablets USP, Do. 2.5 mg. ANDA 200792............ Oxymorphone HCl Par Pharmaceutical, Extended-Release Inc. Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg. ANDA 204538............ Zidovudine Injection Liaoning Chengda USP, 10 mg/mL. Biotechnology Co., Ltd., c/o Ruby Pharma, Inc., 116 Village Blvd, Suite 200, Princeton, NJ 08540. ------------------------------------------------------------------------ Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the applications listed in table 1 in this document, and all amendments and supplements thereto, is hereby withdrawn, effective November 3, 2016. Introduction or delivery for introduction into interstate [[Page 68432]] commerce of products without approved new drug applications violates section 301(a) and (d) of the FD&C 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: September 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-23893 Filed 10-3-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices 68427
DEPARTMENT OF HEALTH AND approval of 44 new drug applications Silver Spring, MD 20993–0002, 301–
HUMAN SERVICES (NDAs) and 158 abbreviated new drug 796–3601.
applications (ANDAs) from multiple
Food and Drug Administration SUPPLEMENTARY INFORMATION: The
applicants. The holders of the
applications notified the Agency in holders of the applications listed in
[Docket No. FDA–2016–N–0002] table 1 in this document have informed
writing that the drug products were no
longer marketed and requested that the FDA that these drug products are no
Hospira, Inc. et al.; Withdrawal of longer marketed and have requested that
Approval of 44 New Drug Applications approval of the applications be
withdrawn. FDA withdraw approval of the
and 158 Abbreviated New Drug
applications under the process in
Applications DATES: Effective Date: November 3, § 314.150(c) (21 CFR 314.150(c)). The
AGENCY: Food and Drug Administration, 2016. applicants have also, by their requests,
HHS. FOR FURTHER INFORMATION CONTACT: waived their opportunity for a hearing.
ACTION: Notice. Florine P. Purdie, Center for Drug Withdrawal of approval of an
Evaluation and Research, Food and application or abbreviated application
SUMMARY: The Food and Drug Drug Administration, 10903 New under § 314.150(c) is without prejudice
Administration (FDA) is withdrawing Hampshire Ave., Bldg. 51, Rm. 6248, to refiling.
TABLE 1
Application No. Drug Applicant
NDA 005264 ...... Heparin Sodium Injection ......................................................... Hospira, Inc., 275 North Field Dr., Bldg. H2–2, Lake Forest,
IL 60045–5046.
NDA 009470 ...... Xylocaine Viscous (lidocaine hydrochloride (HCl)) Solution .... Fresenius Kabi USA LLC, Three Corporate Dr., Lake Zurich,
IL 60047.
NDA 009698 ...... Miltown (meprobamate) Tablets, 200 milligrams (mg) and Meda Pharmaceuticals, Inc., 265 Davidson Ave., Suite 300,
400 mg. Somerset, NJ 08873–4120.
NDA 009939 ...... Senokot Granules (sennosides), 15 mg .................................. Purdue Products, L.P., One Stamford Forum, Stamford, CT
06901.
NDA 010382 ...... Tempra (acetaminophen) Syrup, 160 mg/5 milliliters (mL) ..... Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
88543–4000.
NDA 011228 ...... Liquamar (phenprocoumon) Tablets ........................................ Organon USA Inc., Subsidiary of Merck & Co., Inc., 2000
Galloping Hill Rd., Kenilworth, NJ 07033.
NDA 011613 ...... Ionamin (phentermine resin complex) Capsules, 15 mg and UCB, Inc., 1950 Lake Park Dr., Smyrna, GA 30080.
30 mg.
NDA 011738 ...... Numorphan (oxymorphone HCl) Suppositories, 5 mg ............. Endo Pharmaceuticals, Inc., 100 Endo Blvd., Chadds Ford,
PA 19317.
NDA 012365 ...... Soma Compound (carisoprodol and aspirin) Tablets .............. Meda Pharmaceuticals, Inc.
NDA 012940 ...... Isordil (isosorbide dinitrate) Sublingual Tablets, 2.5 mg, 5 Valeant International Bermuda, c/o Valeant Pharmaceuticals
mg, and 10 mg. North America, LLC, 400 Somerset Corporate Blvd.,
Bridgewater, NJ 08807.
NDA 013483 ...... Drixoral/Disophrol (dexbrompheniramine maleate and Merck Consumer Care, 556 Morris, Ave., Summit, NJ 07901.
pseudoephedrine sulfate) Extended-Release Tablets, 6
mg/120 mg.
NDA 014005 ...... Maxibolin (ethylestrenol) Tablets ............................................. Organon USA Inc.
NDA 017087 ...... Ethrane (enflurane USP) .......................................................... Baxter Healthcare Corp., 32650 N. Wilson Rd., Round Lake,
IL 60073.
NDA 017689 ...... Methadone HCl Syrup .............................................................. Sandoz, Inc., 4700 Sandoz, Dr., Wilson, NC 27893.
NDA 018766 ...... Ansaid (flurbiprofen) Tablets, 50 mg and 100 mg ................... Pharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East 42nd St.,
New York, NY 10017.
NDA 018812 ...... Sulfamethoxazole and Trimethoprim Oral Suspension USP, Teva Pharmaceuticals USA, Inc., 1090 Horsham Rd., P.O.
200 mg/5 mL and 40 mg/5 mL. Box 1090, North Wales, PA 19454.
NDA 019304 ...... Tricor (fenofibrate) Micronized Capsules, 67 mg, 134 mg, AbbVie Inc., 1 N. Waukegan Rd., Dept. PA77/Bldg. AP30,
and 200 mg. North Chicago, IL 60064.
NDA 019384 ...... Noroxin (norfloxacin) Tablets, 400 mg ..................................... Merck Sharp & Dohme Corp., 351 North Sumneytown Pike,
P.O. Box 1000, North Wales, PA 19454.
NDA 020005 ...... Cardene SR (nicardipine HCl) Extended-Release Capsules, Chiesi USA, Inc., 1255 Crescent Green Dr., Suite 250, Cary,
30 mg, 45 mg, and 60 mg. NC 27518.
NDA 020073 ...... Romazicon (flumazenil) Injection ............................................. Hoffman-LaRoche, Inc., c/o Genetech, Inc., 1 DNA Way MS
#241B, South San Francisco, CA 94080–4900.
NDA 020084 ...... Iobenguane Sulfate I–131 Injection, 2.3 millicuries ................. Pharmalucence, 10 DeAngelo Dr., Bedford, MA 01730.
NDA 020107 ...... Novamine (amino acids) Injection ............................................ Baxter Healthcare Corp.
NDA 020229 ...... Leustatin (cladribine) Injection, 1 mg/mL ................................. Janssen Pharmaceuticals Inc., 920 Route 202 South, P.O.
Box 300, Raritan, NJ 08869–0602.
NDA 020251 ...... Zantac (ranitidine HCl) Effervescent Tablets, 25 mg and 150 Glaxo Group Limited, England d/b/a GlaxoSmithKline, Five
mstockstill on DSK3G9T082PROD with NOTICES
mg Zantac (ranitidine HCl) Effervescent Granules, 150 mg. Moore Dr., P.O. Box 13398, Research Triangle Park, NC
27709.
NDA 020312 ...... Univasc (moexipril HCl) Tablets, 7.5 mg and 15 mg ............... UCB, Inc.
NDA 020346 ...... Zyrtec (cetirizine HCl) Syrup, 1 mg/mL ................................... Johnson and Johnson Consumer Inc., McNeil Consumer
Healthcare Division, 7050 Camp Hill Rd., Fort Washington,
PA 19034–2299.
NDA 020410 ...... Gastromark (ferumoxsil) Oral Suspension ............................... AMAG Pharmaceuticals, 100 Haydon Ave., Lexington, MA
02421.
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![68432 Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
commerce of products without Electronic Submissions copies total. One copy will include the
approved new drug applications Submit electronic comments in the information you claim to be confidential
violates section 301(a) and (d) of the following way: with a heading or cover note that states
FD&C Act (21 U.S.C. 331(a) and (d)). • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
Drug products that are listed in table 1 www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
that are in inventory on the date that instructions for submitting comments. Agency will review this copy, including
this notice becomes effective (see the Comments submitted electronically, the claimed confidential information, in
DATES section) may continue to be including attachments, to http:// its consideration of comments. The
dispensed until the inventories have www.regulations.gov will be posted to second copy, which will have the
been depleted or the drug products have the docket unchanged. Because your claimed confidential information
reached their expiration dates or comment will be made public, you are redacted/blacked out, will be available
otherwise become violative, whichever solely responsible for ensuring that your for public viewing and posted on http://
occurs first. comment does not include any www.regulations.gov. Submit both
Dated: September 27, 2016. confidential information that you or a copies to the Division of Dockets
Leslie Kux, third party may not wish to be posted, Management. If you do not wish your
such as medical information, your or name and contact information to be
Associate Commissioner for Policy.
anyone else’s Social Security number, or made publicly available, you can
[FR Doc. 2016–23893 Filed 10–3–16; 8:45 am]
confidential business information, such provide this information on the cover
BILLING CODE 4164–01–P sheet and not in the body of your
as a manufacturing process. Please note
that if you include your name, contact comments and you must identify this
information, or other information that information as ‘‘confidential.’’ Any
DEPARTMENT OF HEALTH AND
identifies you in the body of your information marked as ‘‘confidential’’
HUMAN SERVICES
comments, that information will be will not be disclosed except in
Food and Drug Administration posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
• If you want to submit a comment applicable disclosure law. For more
with confidential information that you information about FDA’s posting of
[Docket No. FDA–2016–N–2880]
do not wish to be made available to the comments to public dockets, see 80 FR
Microbiology Devices Panel of the public, submit the comment as a 56469, September 18, 2015, or access
Medical Devices Advisory Committee; written/paper submission and in the the information at: http://www.fda.gov/
Notice of Meeting; Establishment of a manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
Public Docket; Request for Comments Submissions’’ and ‘‘Instructions’’). default.htm.
Docket: For access to the docket to
AGENCY: Food and Drug Administration, Written/Paper Submissions read background documents or the
HHS. Submit written/paper submissions as electronic and written/paper comments
follows: received, go to http://
ACTION: Notice; establishment of a • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
public docket; request for comments. written/paper submissions): Division of docket number, found in brackets in the
Dockets Management (HFA–305), Food heading of this document, into the
SUMMARY: The Food and Drug and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Administration (FDA) announces a Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
forthcoming public advisory committee • For written/paper comments Management, 5630 Fishers Lane, Rm.
meeting of the Microbiology Devices submitted to the Division of Dockets 1061, Rockville, MD 20852.
Panel of the Medical Devices Advisory Management, FDA will post your FOR FURTHER INFORMATION CONTACT:
Committee. The general function of the comment, as well as any attachments, Aden Asefa, Center for Devices and
committee is to provide advice and except for information submitted, Radiological Health, Food and Drug
recommendations to the Agency on marked and identified, as confidential, Administration, 10903 New Hampshire
FDA’s regulatory issues. The meeting if submitted as detailed in Ave., Silver Spring, MD 20993,
will be open to the public. FDA is ‘‘Instructions.’’ aden.asefa@fda.hhs.gov, 301–796–0400,
establishing a docket for public Instructions: All submissions received or FDA Advisory Committee
comment on this document. must include the Docket No. FDA– Information Line, 1–800–741–8138
DATES: The meeting will be held on 2016–N–2880 for ‘‘Microbiology Devices (301–443–0572 in the Washington, DC
November 9 and 10, 2016, from 8 a.m. Panel of the Medical Devices Advisory area). A notice in the Federal Register
to 6 p.m. Committee; Notice of Meeting; about last minute modifications that
Establishment of a Public Docket; impact a previously announced
ADDRESSES: Gaithersburg Holiday Inn Request for Comments.’’ Received advisory committee meeting cannot
Ballroom, 2 Montgomery Village Ave., comments will be placed in the docket always be published quickly enough to
Gaithersburg, MD 20879. The hotel’s and, except for those submitted as provide timely notice. Therefore, you
telephone number is 301–948–8900. ‘‘Confidential Submissions,’’ publicly should always check the Agency’s Web
Answers to commonly asked questions viewable at http://www.regulations.gov site at http://www.fda.gov/
including information regarding special or at the Division of Dockets AdvisoryCommittees/default.htm and
accommodations due to a disability, Management between 9 a.m. and 4 p.m., scroll down to the appropriate advisory
mstockstill on DSK3G9T082PROD with NOTICES
visitor parking, and transportation may Monday through Friday. committee meeting link, or call the
be accessed at: http://www.fda.gov/ • Confidential Submissions—To advisory committee information line to
AdvisoryCommittees/ submit a comment with confidential learn about possible modifications
AboutAdvisoryCommittees/ information that you do not wish to be before coming to the meeting.
ucm408555.htm. made publicly available, submit your SUPPLEMENTARY INFORMATION:
You may submit comments as comments only as a written/paper Agenda: On November 9, 2016,
follows: submission. You should submit two during session one, the committee will
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Document Created: 2016-10-04 03:04:06
Document Modified: 2016-10-04 03:04:06
| 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. | |
| 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 | 81 FR 68427 |
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