| Page Range | 56976-56978 | |
| FR Document | 2017-25920 |
[Federal Register Volume 82, Number 230 (Friday, December 1, 2017)] [Notices] [Pages 56976-56978] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25920] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6591] Barr Laboratories, Inc. et al.; Withdrawal of Approval of 68 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 68 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of January 2, 2018. FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945. 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 ------------------------------------------------------------------------ ANDA 040135............... Estropipate Tablets Barr Laboratories, USP, 0.75 milligrams Inc., Subsidiary of (mg), 1.5 mg, and 3 Teva Pharmaceuticals mg. USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 040755............... Carisoprodol Tablets Sun Pharmaceutical USP, 350 mg. Industries, Ltd., c/ o Sun Pharmaceutical Industries, Inc., 270 Prospect Plains Rd., Cranbury, NJ 08512. [[Page 56977]] ANDA 062588............... Gentamicin Sulfate in Hospira, Inc., a 0.9% Sodium Chloride Pfizer Company, 275 Injection, North Field Dr., Equivalent to (EQ) Bldg. H1, Lake 1.2 mg base/ Forest, IL 60045. milliliter (mL), EQ 1.4 mg base/mL, EQ 1.6 mg base/mL, EQ 1.8 mg base/mL, EQ 2 mg base/mL, EQ 60 mg base/100 mL, EQ 70 mg base/100 mL, EQ 80 mg base/100 mL, EQ 90 mg base/100 mL, and EQ 100 mg base/100 mL. ANDA 062591............... Kefurox (cefuroxime) ACS Dobfar S.p.A., c/ for Injection USP, o Interchem Corp., EQ 750 mg base/vial, 120 Route 17 North, EQ 1.5 grams (g) Paramus, NJ 07652. base/vial, and EQ 7.5 g base/vial. ANDA 062756............... Primaxin IV (imipenem Merck Sharp & Dohme and cilastatin) for Corp., Subsidiary of Injection USP, 250 Merck & Co., Inc., 1 mg/vial; EQ 250 mg Merck Dr., P.O. Box base/vial and 500 mg/ 100, Whitehouse vial; EQ 500 mg base/ Station, NJ 08889. vial. ANDA 063207............... Cefazolin for Facta Farmaceutici Injection USP, EQ 1 S.p.A., c/o g base/vial. Interchem Corp., 120 Route 17 North, Suite 115, Paramus, NJ 07652. ANDA 063209............... Cefazolin for Do. Injection USP, EQ 10 g base/vial and EQ 20 g base/vial (Pharmacy Bulk Package). ANDA 063214............... Cefazolin for Do. Injection USP, EQ 500 mg base/vial. ANDA 063263............... Amikacin Sulfate Hospira, Inc. Injection USP, EQ 50 mg base/mL. ANDA 065268............... Ceftriaxone for Facta Farmaceutici Injection USP, EQ 1 S.p.A. g base/vial and EQ 2 g base/vial. ANDA 065269............... Ceftriaxone for Do. Injection USP, EQ 10 g base/vial (Pharmacy Bulk Package). ANDA 065348............... Cefotaxime for Cephazone Pharma, Injection USP, EQ 10 LLC, 250 E. Bonita g base/vial Ave., Pomona, CA (Pharmacy Bulk 91767. Package). ANDA 065464............... Cefoxitin for ACS Dobfar S.p.A. Injection USP, EQ 10 g base/vial (Pharmacy Bulk Package). ANDA 065467............... Cefoxitin for Do. Injection USP, EQ 1 g base/vial and EQ 2 g base/vial. ANDA 070048............... Cotrim D.S. Teva Pharmaceuticals (sulfamethoxazole USA, Inc., 425 and trimethoprim) Privet Rd., Horsham, Tablets USP, 800 mg/ PA 19044. 160 mg. ANDA 070195............... Valproic Acid Catalent Pharma Capsules USP, 250 mg. Solutions, LLC, 2725 Scherer Dr. North, St. Petersburg, FL 33716. ANDA 070513............... Tolazamide Tablets Watson Laboratories, USP, 100 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 070514............... Tolazamide Tablets Do. USP, 250 mg. ANDA 071358............... Tolazamide Tablets Sun Pharmaceutical USP, 250 mg. Industries, Inc., 270 Prospect Plains Rd., Cranbury, NJ 08512. ANDA 071359............... Tolazamide Tablets Do. USP, 500 mg. ANDA 071667............... Ibuprofen Tablets Pliva, Inc., USP, 600 mg. Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 071668............... Ibuprofen Tablets Do. USP, 800 mg. ANDA 071735............... Ibuprofen Tablets Contract Pharmacal USP, 200 mg. Corp., c/o SciRegs International Inc., 6333 Summercrest Dr., Columbia, MD 21045. ANDA 071773............... Ibuprofen Tablets Pliva, Inc., USP, 200 mg. Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 073254............... Loperamide Contract Pharmacal Hydrochloride (HCl) Corp. Tablets USP, 2 mg. ANDA 074075............... Clemastine Fumarate Actavis Mid Atlantic, Syrup, EQ 0.5 mg LLC, Subsidiary of base/5 mL. Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 074536............... Haloperidol Oral Do. Solution USP, EQ 1 mg base/mL. ANDA 074782............... Ibuprofen Capsules, Contract Pharmacal 200 mg. Corp. ANDA 074789............... Naproxen Sodium Do. Tablets USP, EQ 200 mg base. ANDA 074931............... Ibuprofen Tablets Do. USP, 200 mg. ANDA 074961............... Cimetidine Tablets Do. USP, 200 mg. ANDA 074963............... Cimetidine Tablets Do. USP, 200 mg. ANDA 075094............... Ranitidine Tablets Do. USP, EQ 75 mg base. ANDA 075588............... Ibuprofen and Do. Pseudoephedrine HCl Tablets USP, 200 mg/ 30 mg. ANDA 077058............... Pantoprazole Sodium Sun Pharmaceutical Delayed-Release Industries, Ltd. Tablets USP, EQ 20 mg base and EQ 40 mg base. ANDA 077172............... Ondansetron Injection Do. USP, EQ 2 mg base/mL. ANDA 077329............... Octreotide Acetate Do. Injection, EQ 0.05 mg base/mL, EQ 0.1 mg base/mL, and EQ 0.5 mg base/mL. ANDA 077330............... Octreotide Acetate Do. Injection, EQ 0.2 mg base/mL. ANDA 077331............... Octreotide Acetate Do. Injection, EQ 1 mg base/mL. ANDA 078108............... Sertraline HCl Do. Tablets, EQ 25 mg base, EQ 50 mg base, and EQ 100 mg base. ANDA 078478............... Torsemide Tablets, 5 Do. mg, 10 mg, 20 mg, and 100 mg. ANDA 083000............... Folic Acid Tablets, 1 Ivax Pharmaceutical mg. USA, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 085549............... Reserpine, Watson Laboratories, Hydralazine HCl, and Inc., Subsidiary of Hydrochlorothiazide Teva Pharmaceuticals Tablets, 0.1 mg/25 USA, Inc. mg/15 mg. ANDA 086109............... Tolbutamide Tablets Do. USP, 500 mg. ANDA 086577............... Trimethobenzamide HCl Do. Injection, 100 mg/mL. [[Page 56978]] ANDA 087191............... Triamcinolone Alpharma U.S. Pharms, Acetonide Lotion Subsidiary of Teva USP, 0.025%. Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 087398............... Spironolactone and Watson Laboratories, Hydrochlorothiazide Inc., Subsidiary of Tablets USP, 25 mg/ Teva Pharmaceuticals 25 mg. USA, Inc. ANDA 088229............... Thioridazine HCl Oral Actavis Mid Atlantic, Solution USP, 100 mg/ LLC, Subsidiary of mL. Teva Pharmaceuticals USA, Inc. ANDA 088563............... Thioridazine HCl Watson Laboratories, Tablets USP, 50 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 088567............... Thioridazine HCl Do. Tablets USP, 25 mg. ANDA 088733............... Meclizine HCl Pliva, Inc., Tablets, 25 mg Subsidiary of Teva (Chewable). Pharmaceuticals USA, Inc. ANDA 088869............... Thioridazine HCl Watson Laboratories, Tablets USP, 150 mg. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 090800............... Quinapril Tablets Sun Pharmaceutical USP, EQ 5 mg base, Industries, Ltd. EQ 10 mg base, EQ 20 mg base, and EQ 40 mg base. ANDA 091177............... Anastrozole Tablets, Do. 1 mg. ANDA 091466............... Letrozole Tablets Do. USP, 2.5 mg. ANDA 200486............... Norethindrone and Mylan Laboratories, Ethinyl Estradiol Ltd., c/o Mylan Tablets USP, 0.5 mg/ Pharmaceuticals, 0.035 mg, 0.75 mg/ Inc., 781 Chestnut 0.035 mg, and 1 mg/ Ridge Rd., P.O. Box 0.035 mg. 4310, Morgantown, WV 26504. ANDA 200488............... Norethindrone and Do. Ethinyl Estradiol Tablets USP, 0.5 mg/ 0.035 mg. ANDA 200489............... Norethindrone and Do. Ethinyl Estradiol Tablets USP, 1 mg/ 0.035 mg. ANDA 201250............... Vancomycin HCl for Teva Pharmaceuticals Injection USP, EQ 5 USA, Inc. g base/vial and EQ 10 g base/vial (Pharmacy Bulk Package). ANDA 201251............... Vancomycin HCl for Do. Injection USP, EQ 500 mg base/vial and EQ 1 g base/vial. ANDA 201828............... Norgestrel and Mylan Laboratories, Ethinyl Estradiol Ltd. Tablets USP, 0.3 mg/ 0.03 mg. ANDA 202203............... Topotecan HCl for Sun Pharmaceutical Injection, EQ 4 mg Industries, Ltd. base/vial. ANDA 202746............... Zoledronic Acid Sun Pharma Global Injection, EQ 4 mg FZE, c/o Sun base/5 mL. Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540. ANDA 202875............... Norgestrel and Mylan Laboratories, Ethinyl Estradiol Ltd. Tablets USP, 0.5 mg/ 0.05 mg. ANDA 203476............... Zolmitriptan Tablets, Sun Pharma Global 2.5 mg and 5 mg. FZE. ANDA 203685............... Irbesartan Tablets Ajanta Pharma Ltd., c/ USP, 75 mg, 150 mg, o Ajanta Pharma USA, and 300 mg. Inc., One Grande Commons, 440 US Highway 22 East, Suite 150, Bridgewater, NJ 08807. ANDA 203838............... Hydrocodone Tris Pharma, Inc., Bitartrate, 2033 Route 130, Chlorpheniramine Monmouth Junction, Maleate, and NJ 08852. Pseudoephedrine HCl Oral Solution, 5 mg/ 4 mg/60 mg per 5 mL. ANDA 203839............... Hydrocodone Do. Bitartrate and Pseudoephedrine HCl Oral Solution, 5 mg/ 60 mg per 5 mL. ------------------------------------------------------------------------ Therefore, approval of the applications listed in table 1 of this document, and all amendments and supplements thereto, is hereby withdrawn as of January 2, 2018. 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: November 27, 2017. Leslie Kux, Associate Commissioner for Policy.. [FR Doc. 2017-25920 Filed 11-30-17; 8:45 am] BILLING CODE 4164-01-P
| 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 | Approval is withdrawn as of January 2, 2018. | |
| Contact | Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945. | |
| FR Citation | 82 FR 56976 |