Document ID: FDA-2012-N-0839-0001
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of 27 Abbreviated New Drug Applications: Ranbaxy Laboratories Limited
Posted Date: 2012-08-22T04:00Z

[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Notices]
[Pages 50702-50703]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20588]

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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.

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[[Page 50703]]

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withdrawn.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 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submit another application to FDA for these withdrawn drug products and 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.

                                 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.
[FR Doc. 2012-20588 Filed 8-21-12; 8:45 am]
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