Document ID: FDA-2014-N-0662-0001
Agency: fda
Document Type: Notice
Title: Aurobindo Pharma Ltd. et al.; Withdrawal of Approval of Eighty-Six
Abbreviated New Drug Applications
Posted Date: 2014-06-19T04:00Z

[Federal Register Volume 79, Number 118 (Thursday, June 19, 2014)]
[Notices]
[Pages 35170-35172]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14288]

[[Page 35170]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0662]

Aurobindo Pharma Ltd. et al.; Withdrawal of Approval of Eighty-
Six Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 86 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that the approval of the applications be withdrawn.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: Effective Date: July 21, 2014.

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

                                 Table 1
------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 065395.................  Cefazolin for         Aurobindo Pharma
                               Injection USP, 500    Ltd., c/o
                               milligrams (mg) and   AuroMedics Pharma
                               1 gram (g).           LLC, 6 Wheeling Rd.
                                                     Dayton, NJ 08810.
ANDA 065481.................  Ceftazidime for        Do.
                               Injection USP, 500
                               mg, 1 g, and 2 g.
ANDA 065482.................  Ceftazidime for        Do.
                               Injection USP, 6 g.
ANDA 065504.................  Ceftriaxone for        Do.
                               Injection USP, 10 g.
ANDA 065505.................  Ceftriaxime for        Do.
                               Injection, 250 mg,
                               500 mg, 1 g, and 2
                               g.
ANDA 065516.................  Cefotaxime for         Do.
                               Injection USP, 10 g.
ANDA 065517.................  Cefotaxime for         Do.
                               Injection USP.
ANDA 077467.................  Nateglinide Tablets,  Teva Pharmaceuticals
                               60 mg and 120 mg.     USA, 1090 Horsham
                                                     Rd., P.O. Box 1090,
                                                     North Wales, PA
                                                     19454.
ANDA 077472.................  Cetirizine            Ranbaxy Laboratories
                               Hydrochloride (HCl)   Limited, c/o
                               Syrup, 5 mg/5         Ranbaxy Inc., 600
                               milliliters (mL).     College Rd. East,
                                                     Princeton, NJ
                                                     08540.
ANDA 077540.................  Zolpidem Tartrate     Synthon
                               Tablets, 5 mg and     Pharmaceuticals,
                               10 mg.                Inc., 9000
                                                     Development Dr.,
                                                     P.O. Box 110487,
                                                     Research Triangle
                                                     Park, NC 27709.
ANDA 077717.................  Ondansetron Orally    Nesher
                               Disintegrating        Pharmaceuticals
                               Tablets USP, 4 mg     (USA) LLC, 13910
                               and 8 mg.             St. Charles Rock
                                                     Rd., Bridgeton, MO
                                                     63044.
ANDA 077730.................  Pravastatin Sodium    Pliva HRVATSKA, c/o
                               Tablets, 10 mg, 20    Barr Laboratories,
                               mg, 30 mg, 40 mg,     Inc., 400 Chestnut
                               and 80 mg.            Ridge Rd.,
                                                     Woodcliff Lake, NJ
                                                     07677.
ANDA 077826.................  Fenoldopam Mesylate   Teva Parenteral
                               Injection USP, 10     Medicines, Inc., 19
                               mg (base)/mL.         Hughes, Irvine, CA
                                                     92618.
ANDA 077888.................  Ciprofloxacin         Baxter Healthcare
                               Injection USP, 2 mg/  Corp., 1620
                               mL.                   Waukegan Rd., McGaw
                                                     Park, IL 60085.
ANDA 077905.................  Topiramate Tablets,   Pliva HRVATSKA, c/o
                               25 mg, 50 mg, 100     Barr Laboratories,
                               mg, and 200 mg.       Inc.
ANDA 078016.................  Zolpidem Tartrate     Mylan
                               Tablets, 5 mg and     Pharmaceuticals,
                               10 mg.                Inc., 781 Chestnut
                                                     Ridge Rd., P.O. Box
                                                     4310, Morgantown,
                                                     WV 26505-4310.
ANDA 078053.................  Sertraline HCl Oral   Ranbaxy Laboratories
                               Concentrate, 20 mg/   Limited, c/o
                               mL.                   Ranbaxy Inc.
ANDA 078114.................  Ciprofloxacin         Bedford
                               Injection USP in 5%   Laboratories, 300
                               Dextrose, 2 mg/mL.    Northfield Rd.,
                                                     Bedford, OH 44146.
ANDA 078132.................  Ibuprofen Tablets     Quality Regulatory
                               USP, 400 mg, 600      Consultants, U.S.
                               mg, and 800 mg.       Agent for Northstar
                                                     Healthcare
                                                     Holdings, 501 Ivy
                                                     Lake Dr., Forest,
                                                     VA 24551.
ANDA 078187.................  Risperidone Tablets   Synthon
                               USP, 0.25 mg, 0.5     Pharmaceuticals,
                               mg, 1 mg, 2 mg, 3     Inc.
                               mg, and 4 mg.
ANDA 078322.................  Anastrozole Tablets,   Do.
                               1 mg.
ANDA 078448.................  Ranitidine HCl        Ranbaxy Inc., U.S.
                               Solution, 15 mg/mL.   Agaent for Ranbaxy
                                                     Laboratories
                                                     Limited.
ANDA 078606.................  Mitoxantrone          Washington Food and
                               Injection USP.        Drug Consultants,
                                                     U.S. Agent for
                                                     Fresenius Kabi
                                                     Oncology Plc., 3631
                                                     Martins Dairy
                                                     Circle, Olney, MD
                                                     20832.
ANDA 080043.................  Nitrofurantoin        Sandoz Inc., 2555 W.
                               Tablets, 50 mg and    Midway Blvd.,
                               100 mg.               Broomfield, CO
                                                     80038-0446.
ANDA 080203.................  Potassium Chloride    Baxter Healthcare
                               Injection USP, 2      Corp., 25212 W. IL
                               milliequivalents/mL.  Route 120, Round
                                                     Lake, IL 70073.
ANDA 080642.................  Hydrocortisone        Sandoz Inc.
                               Tablets, 20 mg.
ANDA 081142.................  Aminophylline         Teva Parenteral
                               Injection USP, 25     Medicines, Inc.
                               mg/mL.
ANDA 081169.................  Glycopyrrolate         Do.
                               Injection USP, 0.2
                               mg/mL.
ANDA 081266.................  Methyprednisolone      Do.
                               Sodium Succinate
                               for Injection USP,
                               125 mg.

[[Page 35171]]

 
ANDA 081267.................  Methylprednisolone     Do.
                               Sodium Succinate
                               for Injection USP,
                               500 mg.
ANDA 081268.................  Methyprednisolone      Do.
                               Sodium Succinate
                               for Injection USP,
                               1 g.
ANDA 081278.................  Leucovorin Calcium     Do.
                               for Injection, 50
                               mg/vial.
ANDA 083254.................  Halothane USP.......  Hospira, Inc., 275
                                                     North Field Dr.,
                                                     Lake Forest, IL
                                                     60045.
ANDA 083263.................  Alcohol in Dextrose    Do.
                               Injection USP, 5%/
                               5%.
ANDA 083306.................  Niacin Tablets, 50    Sandoz Inc.
                               mg.
ANDA 083486.................  Isoproterenol HCl     Baxter Healthcare
                               Injection USP, 0.2    Corp.
                               mg/mL.
ANDA 084051.................  Dextroamphetamine     Shire Development
                               Sulfate Tablets       Inc., 725
                               USP, 5 mg and 10 mg.  Chesterbrook Blvd.,
                                                     Wayne, PA 19087.
ANDA 084233.................  Promethazine HCl      Sandoz Inc.
                               Tablets, 12.5 mg.
ANDA 084472.................  Folic Acid Capsules,   Do.
                               1 mg.
ANDA 084827.................  Hydrochlorothiazide    Do.
                               and Reserpine
                               Tablets, 25 mg/
                               0.125 mg.
ANDA 085034.................  Phendimetrazine        Do.
                               Tartrate Tablets,
                               35 mg.
ANDA 085133.................  Imipramine HCl         Do.
                               Tablets, 50 mg.
ANDA 085200.................  Imipramine HCl         Do.
                               Tablets, 10 mg.
ANDA 085213.................  Hydrochlorothiazide    Do.
                               and Reserpine
                               Tablets, 50 mg/
                               0.125 mg.
ANDA 085302.................  Estrogens,             Do.
                               Esterified Tablets,
                               1.25 mg.
ANDA 085362.................  Novocaine (procaine   Hospira, Inc.
                               HCl Injection USP).
ANDA 085370.................  Dextroamphetamine     Sandoz Inc.
                               Sulfate Tablets, 5
                               mg.
ANDA 085371.................  Dextroamphetamine      Do.
                               Sulfate Tablets, 10
                               mg.
ANDA 085402.................  Phendimetrazine        Do.
                               Tartrate Tablets,
                               35 mg.
ANDA 085601.................  Triamcinolone          Do.
                               Tablets, 4 mg.
ANDA 085633.................  Phendimetrazine        Do.
                               Tartrate Capsules,
                               35 mg.
ANDA 085671.................  Phentermine HCl        Do.
                               Tablets, 8 mg.
ANDA 085689.................  Phentermine HCl        Do.
                               Tablets USP, 8 mg.
ANDA 085694.................  Phendimetrazine        Do.
                               Tartrate Capsules,
                               35 mg.
ANDA 085702.................  Phendimetrazine        Do.
                               Tartrate Capsules,
                               35 mg.
ANDA 085830.................  Phendimetrazine        Do.
                               Tartrate Tablets,
                               35 mg.
ANDA 085852.................  A-Methapred           Hospira, Inc.
                               (methylprednisolone
                               sodium succinate
                               for injection USP),
                               1,000 mg/vial.
ANDA 085853.................  A-Methapred            Do.
                               (methylprednisolone
                               sodium succinate
                               for injection USP),
                               40 mg/vial.
ANDA 085854.................  A-Methapred            Do.
                               (methylprednisolone
                               sodium succinate
                               for injection USP),
                               500 mg/vial.
ANDA 085929.................  A-Hydrocort           Hospira, Inc.
                               (hydrocortisone
                               sodium succinate
                               for injection USP),
                               100 mg/vial.
ANDA 085930.................  A-Hydrocort            Do.
                               (hydrocortisone
                               sodium succinate
                               for injection USP),
                               250 mg/vial.
ANDA 085931.................  A-Hydrocort            Do.
                               (hydrocortisone
                               sodium succinate
                               for injection USP),
                               500 mg/vial.
ANDA 085932.................  A-Hydrocort            Do.
                               (hydrocortisone
                               sodium for
                               injection USP),
                               1,000 mg/val.
ANDA 086370.................  Phendimetrazine       Sandoz Inc.
                               Tartrate Tablets,
                               35 mg.
ANDA 086589.................  Barbidonna Tablets    Meda
                               (phenobarbital,       Pharmaceuticals,
                               hyoscyamine           Meda
                               sulfate,              Pharmaceuticals,
                               scopolamine           Inc., 265 Davidson
                               hydrobromide, and     Ave., Suite 300,
                               atropine sulfate).    Somerset, NJ 08873-
                                                     4120.
ANDA 086590.................  Barbidonna Elixir      Do.
                               (phenobarbital,
                               hyoscyamine
                               sulfate, atropine
                               sulfate,
                               scopolamine
                               hydrobromide).
ANDA 086664.................  Butibel Elixir         Do.
                               (sodium
                               butabarbital and
                               belladonna
                               extract), 15 mg/5
                               mL and 15 mg/5 mL.
ANDA 087208.................  Phentermine HCl       Sandoz Inc.
                               Capsules, 30 mg.
ANDA 087223.................  Phentermine HCl        Do.
                               Capsules, 30 mg.
ANDA 087759.................  Prochlorperazine      Baxter Healthcare
                               Edisylate Injection   Corp.
                               USP.
ANDA 087572.................  Barbidonna No. 2      Meda
                               Tablets               Pharmaceuticals.
                               (phenobarbital,
                               hyoscyamine
                               sulfate, atropine
                               sulfate, and
                               scopolamine
                               hydrobromide) 32
                               mg, 0.1286 mg,
                               0.025 mg, and
                               0.0074 mg.
ANDA 088099.................  Heparin Lock Flush    Hospira, Inc.
                               Solution USP, 2,500
                               units/Ml.
ANDA 088175.................  Chlorpropamide        Par Pharmaceutical,
                               Tablets, 100 mg.      Inc., One Ram Ridge
                                                     Rd., Spring Valley,
                                                     NY 10977.
ANDA 088176.................  Chlorpropamide         Do.
                               Tablets, 250 mg.
ANDA 088184.................  Hydroxyzine HCl       Fresenius Kabi USA,
                               Injection USP, 25     LLC, Three
                               mg/mL.                Corporate Dr., Lake
                                                     Zurich, IL 60047.
ANDA 088185.................  Hydroxyzine HCl        Do.
                               Injection USP, 50
                               mg/mL.
ANDA 088330.................  1.5% Lidocain HCl     Hospira, Inc.
                               Injection USP.
ANDA 089158.................  Methotrexate          Pharmachemie B.V., c/
                               Injection USP, 25     o Teva Parenteral
                               mg/mL.                Medicines, Inc., 19
                                                     Hughes, Irvine, CA
                                                     92618.

[[Page 35172]]

 
ANDA 089420.................  Azdone Tablets        Schwarz Pharma,
                               (hydrocodone          Inc., c/o UCB,
                               bitartrate 5 mg and   Inc., 1950 Lake
                               aspirin 500 mg).      Park Dr., Smyrna,
                                                     GA 30080.
ANDA 090183.................  Cetirizine HCl        Ranbaxy Laboratories
                               Syrup, 5 mg/5mL.      Limited, c/o
                                                     Ranbaxy Inc.
ANDA 090196.................  Letrozole Tablets     Synthon
                               USP, 2.5 mg.          Pharmaceuticals,
                                                     Inc.
ANDA 090464.................  Mycophenolate         Dr. Reddy's
                               Mofetil Tablets,      Laboratories
                               500 mg.               Limited, c/o Dr.
                                                     Reddy's
                                                     Laboratories, Inc.,
                                                     200 Somerset
                                                     Corporate Blvd.,
                                                     7th Floor,
                                                     Bridgewater, NJ
                                                     08807.
ANDA 090567.................  Polyethylene Glycol   Paddock
                               3350 Powder for       Laboratories, LLC,
                               Oral Solution.        a Perrigo Co., 3940
                                                     Quebec Ave. North,
                                                     Minneapolis, MN
                                                     55427.
ANDA 090712.................  Polyethylene Glycol    Do.
                               3350 and
                               Electrolytes for
                               Oral Solution.
ANDA 090769.................  Clenz-Lyte             Do.
                               (polyethylene glyol
                               3350 and
                               electrolytes for
                               oral solution).
ANDA 091315.................  Mycophenolalte        Dr. Reddy's
                               Mofetil Capsules      Laboratories
                               USP, 250 mg.          Limited, c/o Dr.
                                                     Reddy's
                                                     Laboratories, Inc.
------------------------------------------------------------------------

    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 July 21, 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.

    Dated: June 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14288 Filed 6-18-14; 8:45 am]
BILLING CODE 4164-01-P