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Eli Lilly and Company, et al.; Withdrawal of Approval of 3 New Drug Applications and 41 Abbreviated New Drug Applications

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is withdrawing approval of 3 new drug applications and 41 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Effective May 22, 2014.

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Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-796-3601.

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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 § 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 § 314.150(c) is without prejudice to refiling.

Table 1—Requests To Withdraw Approval of Applications

Application No.DrugApplicant
NDA 050440Keflet (cephalexin) TabletsEli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285.
NDA 050614Keftab (cephalexin hydrochloride) TabletsDo.
NDA 050673Ceclor CD (cefaclor) TabletsDo.
ANDA 075457Famotidine Tablets USP, 20 milligrams (mg) and 40 mgMylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26505-4310.
ANDA 075559Butorphanol Tartrate Injection USP, 1 mg/milliliter (mL) and 2 mg/mLHospira, Inc., 275 North Field Dr., Lake Forest, IL 60045.
ANDA 075572Buspirone HCl Tablets USP, 5 mg, 10 mg, and 15 mgNesher Pharmaceuticals (USA) LLC, 13910 St. Charles Rock Rd., Bridgeton, MO 63044.
ANDA 075594Pamidronate Disodium for Injection, 30 mg/vial and 90 mg/vialTeva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA 92618.
ANDA 075609Doxazosin Mesylate Tablets, 1 mg, 2 mg, 4 mg, and 8 mgNesher Pharmacueticals (USA) LLC.
ANDA 075613Bupropion HCl Tablets, 75 mg and 100 mgSandoz Inc., 2555 W. Midway Blvd., Broomfield, CO 80038-0446.
ANDA 075627Acyclovir Injection, 50 mg/mLTeva Parenteral Medicines, Inc.
ANDA 075730Thiotepa for Injection USP, 15 mg/vial and 30 mg/vialDo.
ANDA 075793Famotidine Tablets USP, 20 mg and 40 mgSandoz Inc.
ANDA 075847Oxaprozin Tablets USP, 600 mgMylan Pharmaceuticals, Inc.
ANDA 075905Famotidine Injection, 10 mg/mLHospira, Inc.
ANDA 075943Etodolac Extended-Release Tablets, 400 mg, 500 mg, and 600 mgSandoz Inc.
ANDA 075950Fluvoxamine Maleate Tablets, 50 mg and 100 mgMylan Pharmaceuticals, Inc.
ANDA 076018Amiodarone HCl Injection, 50 mg/mLBedford Laboratories, 300 Northfield Rd., Bedford, OH 44146.
ANDA 076042Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mgMylan Pharmaceuticals, Inc.
ANDA 076044Potassium Chloride Extended-Release Tablets USP, 20 milliequivalentsNesher Pharmaceuticals (USA) LLC.
ANDA 076088Amiodarone HCl Injection, 50 mg/mLBedford Laboratories.
ANDA 076193Propafenone HCl Tablets, 150 mg, 225 mg, and 300 mgNesher Pharmaceuticals (USA) LLC.
ANDA 076259Milrinone Lacate in 5% Dextrose InjectionBaxter Healthcare Corp., 25212 W. Illinois Route 120, Round Lake, IL 60073.
ANDA 076299Amiodarone HCl Injection, 50 mg/mLBedford Laboratories.
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ANDA 076315Topiramate Tablets, 25 mg, 100 mg, and 200 mgBarr Laboratories, Inc., an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 076372Brimonidine Tartrate Ophthalmic Solution, 0.2%Teva Parenteral Medicines, Inc.
ANDA 076398Tamoxifen Citrate Tablets USP, 10 mg and 20 mgAegis Pharmaceuticals PLC, c/o GlobePharm Inc., 313 Pine St., Suite 204, Deerfield, IL 60015.
ANDA 076424Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mgPliva Inc., c/o Barr Laboratories Inc., an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, U.S. Agent, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 076448Topiramate Capsules, 15 mg and 25 mgBarr Laboratories, Inc.
ANDA 076529Loratadine Syrup (loratadine oral solution USP), 1 mg/mLRanbaxy Laboratories Limited, c/o Ranbaxy Inc., U.S., 600 College Rd. East, Princeton, NJ 08540.
ANDA 076540Sertraline HCl Tablets, 25 mg, 50 mg, and 100 mgMylan Pharmaceuticals, Inc.
ANDA 076612Benazepril HCl and Hydrochlorothiazide Tablets, 5 mg/6.25 mg, 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mgDo.
ANDA 076640Metoprolol Succinate Extended-Release Tablets, 100 mg and 200 mgNesher Pharmaceuticals (USA) LLC.
ANDA 076865Fluticasone Proprionate Cream, 0.05%Do.
ANDA 076982Prednisolone Sodium Phosphate Oral Solution USP, 5 mg/5 mLDo.
ANDA 076992Ciprofloxacin Injection USP, 10 mg/mLBedford Laboratories.
ANDA 076993Ciprofloxacin Injection USP, 10 mg/mLDo.
ANDA 077074Lorazepam Injection USP (Preservative-Free), 2 mg/mL and 4 mg/mLDo.
ANDA 077076Lorazepam Injection USP, 2 mg/mL and 4 mg/mL, 10 mL per vialDo.
ANDA 077080Amlodipine Besylate Tablets, 2.5 mg, 5 mg, and 10 mgSynthon Pharmaceuticals, Inc., 9000 Development Dr., P.O. Box 110487, Research Triangle Park, NC 27709.
ANDA 077085Leflunomide Tablets, 10 mg and 20 mgSandoz Inc.
ANDA 077311Hydromorphone HCl Tablets USP, 2 mg, 4 mg, and 8 mgNesher Pharmaceuticals (USA) LLC.
ANDA 085917Acetaminophen and Codeine Phosphate Tablets, 30 mgSandoz Inc.
ANDA 087423Acetaminophen and Codeine Phosphate Tablets, 300 mg/60 mgDo.
ANDA 087433Acetaminophen and Codeine Phosphate Tablets, 300 mg/15 mgDo.

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 May 22, 2014. Introduction or delivery for introduction into interstate 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.

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Dated: April 17, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2014-09124 Filed 4-21-14; 8:45 am]