Barr Laboratories, Inc. et al.; Withdrawal of Approval of 68 Abbreviated New Drug Applications
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1 This document is scheduled to be published in the Federal Register on 12/01/2017 and available online at and on FDsys.gov P 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD , 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 (c) (21
2 2 CFR (c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under (c) is without prejudice to refiling Table 1 ANDA Estropipate Tablets USP, 0.75 milligrams (), 1.5, and 3 ANDA Carisoprodol Tablets USP, 350 ANDA Gentamicin Sulfate in 0.9% Sodium Chloride Injection, Equivalent to (EQ) 1.2 base/milliliter (ml), EQ 1.4 base/ml, EQ 1.6 base/ml, EQ 1.8 base/ml, EQ 2 base/ml, EQ 60 base/100 ml, EQ 70 base/100 ml, EQ 80 base/100 ml, EQ 90 base/100 ml, and EQ 100 base/100 ml ANDA ANDA Kefurox (cefuroxime) for Injection USP, EQ 750 base/vial, EQ 1.5 grams (g) base/vial, and EQ 7.5 g base/vial Primaxin IV (imipenem and cilastatin) for Injection USP, 250 /vial; EQ 250 base/vial and 500 /vial; EQ 500 base/vial Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc., 270 Prospect Plains Rd., Cranbury, NJ Hospira, Inc., a Pfizer Company, 275 North Field Dr., Bldg. H1, Lake Forest, IL ACS Dobfar S.p.A., c/o Interchem Corp., 120 Route 17 North, Paramus, NJ Merck Sharp & Dohme Corp., Subsidiary of Merck & Co., Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ ANDA Cefazolin for Injection USP, EQ 1 Facta Farmaceutici S.p.A., c/o
3 3 ANDA ANDA ANDA ANDA ANDA ANDA ANDA g base/vial Interchem Corp., 120 Route 17 North, Suite 115, Paramus, NJ Cefazolin for Injection USP, EQ 10 g base/vial and EQ 20 g base/vial (Pharmacy Bulk Cefazolin for Injection USP, EQ 500 base/vial Amikacin Sulfate Injection USP, EQ 50 base/ml Ceftriaxone for Injection USP, EQ 1 g base/vial and EQ 2 g base/vial Ceftriaxone for Injection USP, EQ 10 g base/vial (Pharmacy Bulk Cefotaxime for Injection USP, EQ 10 g base/vial (Pharmacy Bulk Cefoxitin for Injection USP, EQ 10 g base/vial (Pharmacy Bulk ANDA Cefoxitin for Injection USP, EQ 1 g base/vial and EQ 2 g base/vial ANDA Cotrim D.S. (sulfamethoxazole and trimethoprim) Tablets USP, 800 /160 ANDA Valproic Acid Capsules USP, 250 Hospira, Inc. Facta Farmaceutici S.p.A. Cephazone Pharma, LLC, 250 E. Bonita Ave., Pomona, CA ACS Dobfar S.p.A. Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA Catalent Pharma Solutions, LLC, 2725 Scherer Dr. North, St. Petersburg, FL ANDA Tolazamide Tablets USP, 100 Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA ANDA Tolazamide Tablets USP, 250
4 4 ANDA Tolazamide Tablets USP, 250 Sun Pharmaceutical Industries, Inc., 270 Prospect Plains Rd., Cranbury, NJ ANDA Tolazamide Tablets USP, 500 ANDA Ibuprofen Tablets USP, 600 Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA ANDA Ibuprofen Tablets USP, 800 ANDA Ibuprofen Tablets USP, 200 Contract Pharmacal Corp., c/o SciRegs International Inc., 6333 Summercrest Dr., Columbia, MD ANDA Ibuprofen Tablets USP, 200 Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA ANDA ANDA Loperamide Hydrochloride (HCl) Tablets USP, 2 Clemastine Fumarate Syrup, EQ 0.5 base/5 ml Haloperidol Oral Solution USP, EQ 1 base/ml Contract Pharmacal Corp. Actavis Mid Atlantic, LLC, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA ANDA Ibuprofen Capsules, 200 Contract Pharmacal Corp. ANDA Naproxen Sodium Tablets USP, EQ 200 base ANDA Ibuprofen Tablets USP, 200 ANDA Cimetidine Tablets USP, 200 ANDA Cimetidine Tablets USP, 200 ANDA Ranitidine Tablets USP, EQ 75 base ANDA ANDA Ibuprofen and Pseudoephedrine HCl Tablets USP, 200 /30 Pantoprazole Sodium Delayed- Release Tablets USP, EQ 20 base and EQ 40 base Sun Pharmaceutical Industries, Ltd.
5 5 ANDA Ondansetron Injection USP, EQ 2 base/ml ANDA ANDA Octreotide Acetate Injection, EQ 0.05 base/ml, EQ 0.1 base/ml, and EQ 0.5 base/ml Octreotide Acetate Injection, EQ 0.2 base/ml ANDA Octreotide Acetate Injection, EQ 1 base/ml ANDA ANDA Sertraline HCl Tablets, EQ 25 base, EQ 50 base, and EQ 100 base Torsemide Tablets, 5, 10, 20, and 100 ANDA Folic Acid Tablets, 1 Ivax Pharmaceutical USA, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA ANDA Reserpine, Hydralazine HCl, and Hydrochlorothiazide Tablets, 0.1 /25 /15 ANDA Tolbutamide Tablets USP, 500 ANDA ANDA ANDA ANDA Trimethobenzamide HCl Injection, 100 /ml Triamcinolone Acetonide Lotion USP, 0.025% Spironolactone and Hydrochlorothiazide Tablets USP, 25 /25 Thioridazine HCl Oral Solution USP, 100 /ml Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Alpharma U.S. Pharms, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Actavis Mid Atlantic, LLC, Subsidiary of Teva Pharmaceuticals USA, Inc.
6 6 ANDA Thioridazine HCl Tablets USP, 50 ANDA Thioridazine HCl Tablets USP, 25 ANDA ANDA ANDA Meclizine HCl Tablets, 25 (Chewable) Thioridazine HCl Tablets USP, 150 Quinapril Tablets USP, EQ 5 base, EQ 10 base, EQ 20 base, and EQ 40 base Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA Anastrozole Tablets, 1 ANDA Letrozole Tablets USP, 2.5 ANDA ANDA ANDA ANDA ANDA ANDA ANDA Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 /0.035, 0.75 /0.035, and 1 /0.035 Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 /0.035 Norethindrone and Ethinyl Estradiol Tablets USP, 1 /0.035 Vancomycin HCl for Injection USP, EQ 5 g base/vial and EQ 10 g base/vial (Pharmacy Bulk Vancomycin HCl for Injection USP, EQ 500 base/vial and EQ 1 g base/vial Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 /0.03 Topotecan HCl for Injection, EQ 4 base/vial ANDA Zoledronic Acid Injection, EQ 4 base/5 ml Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Sun Pharmaceutical Industries, Ltd. Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV Teva Pharmaceuticals USA, Inc. Mylan Laboratories, Ltd. Sun Pharmaceutical Industries, Ltd. Sun Pharma Global FZE, c/o Sun Pharmaceutical Industries, Inc., 2
7 7 ANDA ANDA ANDA ANDA ANDA Norgestrel and Ethinyl Estradiol Tablets USP, 0.5 /0.05 Zolmitriptan Tablets, 2.5 and 5 Irbesartan Tablets USP, 75, 150, and 300 Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl Oral Solution, 5 /4 /60 per 5 ml Hydrocodone Bitartrate and Pseudoephedrine HCl Oral Solution, 5 /60 per 5 ml Independence Way, Princeton, NJ Mylan Laboratories, Ltd. Sun Pharma Global FZE Ajanta Pharma Ltd., c/o Ajanta Pharma USA, Inc., One Grande Commons, 440 US Highway 22 East, Suite 150, Bridgewater, NJ Tris Pharma, Inc., 2033 Route 130, Monmouth Junction, NJ Therefore, approval of the applications listed in table 1 of this document, and all amendments and supplements thereto, is hereby withdrawn as of [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. 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.
8 8 Leslie Kux, Associate Commissioner for Policy. [FR Doc Filed: 11/30/2017 8:45 am; Publication Date: 12/1/2017]
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