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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0839]

Ranbaxy Laboratories Limited; Withdrawal of Approval of 27 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 27 abbreviated new drug applications (ANDAs) held by Ranbaxy Laboratories Ltd., c/o Ranbaxy Inc. (Ranbaxy), 600 College Rd. East, Princeton, NJ 08540. The drug products are no longer marketed, and Ranbaxy has requested that the approval of the applications be withdrawn.
DATES: Effective date:September 21, 2012.
FOR FURTHER INFORMATION CONTACT: 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.
SUPPLEMENTARY INFORMATION:

The drug products listed in table 1 in this document are no longer marketed, and Ranbaxy has requested that FDA withdraw approval of the applications. The company has also waived its opportunity for a hearing. Ranbaxy requested withdrawal of approval under a Consent Decree of Permanent Injunction (Decree) entered inUnited Statesv.Ranbaxy Laboratories, Ltd. et al.,JFM 12-250 (D. Md.) on January 26, 2012. The Decree specifies that Ranbaxy must never submit another application to FDA for these withdrawn drug products and must never transfer these ANDAs to a third party.

Table 1 Application No. Drug 064155 Cefaclor for Oral Suspension USP, 375 milligrams (mg)/5 milliliters (mL). 064156 Cefaclor Capsules USP, 250 mg and 500 mg. 064164 Cefaclor for Oral Suspension USP, 250 mg/5 mL. 064165 Cefaclor for Oral Suspension USP, 187 mg/5 mL. 064166 Cefaclor for Oral Suspension USP, 125 mg/5 mL. 065015 Cefadroxil Capsules USP, 500 mg. 065018 Cefadroxil Tablets USP, 1 gram. 065043 Cefuroxime Axetil Tablets USP, 125 mg, 250 mg, and 500 mg. 065080 Dispermox (amoxicillin tablets for oral suspension USP), 200 mg and 400 mg. 065092 Raniclor (cefaclor chewable tablets USP), 125 mg, 187 mg, 250 mg, and 375 mg. 065100 Panixine Disperdose (cephalexin tablets for oral suspension USP), 125 mg and 250 mg. 065159 Dispermox (amoxicillin tablets for oral suspension USP), 600 mg. 065198 Cefprozil Tablets USP, 250 mg and 500 mg. 065202 Cefprozil for Oral Suspension USP, 125 mg/5 mL and 250 mg/5 mL. 075226 Etodolac Tablets USP, 400 mg and 500 mg. 076021 Terazosin Hydrochloride (HCl) Capsules, 1 mg, 2 mg, 5 mg, and 10 mg. 076220 Ofloxacin Tablets, 200 mg, 300 mg, and 400 mg. 076386 Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mg. 076413 Metformin HCl Extended-Release Tablets USP, 500 mg. 076445 Pravastatin Sodium Tablets USP, 10 mg, 20 mg, 40 mg, and 80 mg. 076457 Ganciclovir Capsules, 250 mg and 500 mg. 076580 Fosinopril Sodium Tablets USP, 10 mg, 20 mg, and 40 mg. 076875 Glimepiride Tablets USP, 1 mg, 2 mg, 4 mg, and 8 mg. 076951 Nitrofurantoin/Nitrofurantoin Macrocrystalline Capsules, 75 mg/25 mg. 077211 Metformin HCl Extended-Release Tablets USP, 750 mg. 077327 Zidovudine Tablets USP, 300 mg. 078849 Ramipril Capsules, 5 mg and 10 mg.

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 September 21, 2012. 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)).

Dated: August 15, 2012. Douglas C. Throckmorton, Deputy Director, Center for Drug Evaluation and Research.