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 The drug products are no longer marketed, and Ranbaxy has requested that the approval of the applications be withdrawn.
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.
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 in United States v. 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 The Decree specifies that Ranbaxy must never submit another application to FDA for these withdrawn drug products and must never transfer these ANDAs to a third party.
|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.
[FR Doc. 2012-20588 Filed 8-21-12; 8:45 am]
BILLING CODE 4160-01-P