Document ID: FDA-2014-N-0398-0001
Agency: fda
Document Type: Notice
Title: Eli Lilly and Company, et al.; Withdrawal of Approval of 3 New Drug Applications and 41 Abbreviated New Drug Applications
Posted Date: 2014-04-22T04:00Z

[Federal Register Volume 79, Number 77 (Tuesday, April 22, 2014)]
[Notices]
[Pages 22501-22502]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09124]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0398]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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withdrawn.

DATES: Effective May 22, 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--Requests To Withdraw Approval of Applications
------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 050440.............  Keflet (cephalexin)      Eli Lilly and Co.,
                          Tablets.                 Lilly Corporate
                                                   Center, Indianapolis,
                                                   IN 46285.
NDA 050614.............  Keftab (cephalexin       Do.
                          hydrochloride) Tablets.
NDA 050673.............  Ceclor CD (cefaclor)     Do.
                          Tablets.
ANDA 075457............  Famotidine Tablets USP,  Mylan Pharmaceuticals,
                          20 milligrams (mg) and   Inc., 781 Chestnut
                          40 mg.                   Ridge Rd., P.O. Box
                                                   4310, Morgantown, WV
                                                   26505-4310.
ANDA 075559............  Butorphanol Tartrate     Hospira, Inc., 275
                          Injection USP, 1 mg/     North Field Dr., Lake
                          milliliter (mL) and 2    Forest, IL 60045.
                          mg/mL.
ANDA 075572............  Buspirone HCl Tablets    Nesher Pharmaceuticals
                          USP, 5 mg, 10 mg, and    (USA) LLC, 13910 St.
                          15 mg.                   Charles Rock Rd.,
                                                   Bridgeton, MO 63044.
ANDA 075594............  Pamidronate Disodium     Teva Parenteral
                          for Injection, 30 mg/    Medicines, Inc., 19
                          vial and 90 mg/vial.     Hughes, Irvine, CA
                                                   92618.
ANDA 075609............  Doxazosin Mesylate       Nesher Pharmacueticals
                          Tablets, 1 mg, 2 mg, 4   (USA) LLC.
                          mg, and 8 mg.
ANDA 075613............  Bupropion HCl Tablets,   Sandoz Inc., 2555 W.
                          75 mg and 100 mg.        Midway Blvd.,
                                                   Broomfield, CO 80038-
                                                   0446.
ANDA 075627............  Acyclovir Injection, 50  Teva Parenteral
                          mg/mL.                   Medicines, Inc.
ANDA 075730............  Thiotepa for Injection   Do.
                          USP, 15 mg/vial and 30
                          mg/vial.
ANDA 075793............  Famotidine Tablets USP,  Sandoz Inc.
                          20 mg and 40 mg.
ANDA 075847............  Oxaprozin Tablets USP,   Mylan Pharmaceuticals,
                          600 mg.                  Inc.
ANDA 075905............  Famotidine Injection,    Hospira, Inc.
                          10 mg/mL.
ANDA 075943............  Etodolac Extended-       Sandoz Inc.
                          Release Tablets, 400
                          mg, 500 mg, and 600 mg.
ANDA 075950............  Fluvoxamine Maleate      Mylan Pharmaceuticals,
                          Tablets, 50 mg and 100   Inc.
                          mg.
ANDA 076018............  Amiodarone HCl           Bedford Laboratories,
                          Injection, 50 mg/mL.     300 Northfield Rd.,
                                                   Bedford, OH 44146.
ANDA 076042............  Fluconazole Tablets, 50  Mylan Pharmaceuticals,
                          mg, 100 mg, 150 mg,      Inc.
                          and 200 mg.
ANDA 076044............  Potassium Chloride       Nesher Pharmaceuticals
                          Extended-Release         (USA) LLC.
                          Tablets USP, 20
                          milliequivalents.
ANDA 076088............  Amiodarone HCl           Bedford Laboratories.
                          Injection, 50 mg/mL.
ANDA 076193............  Propafenone HCl          Nesher Pharmaceuticals
                          Tablets, 150 mg, 225     (USA) LLC.
                          mg, and 300 mg.
ANDA 076259............  Milrinone Lacate in 5%   Baxter Healthcare
                          Dextrose Injection.      Corp., 25212 W.
                                                   Illinois Route 120,
                                                   Round Lake, IL 60073.
ANDA 076299............  Amiodarone HCl           Bedford Laboratories.
                          Injection, 50 mg/mL.

[[Page 22502]]

 
ANDA 076315............  Topiramate Tablets, 25   Barr Laboratories,
                          mg, 100 mg, and 200 mg.  Inc., an indirect,
                                                   wholly owned
                                                   subsidiary of Teva
                                                   Pharmaceuticals USA,
                                                   400 Chestnut Ridge
                                                   Rd., Woodcliff Lake,
                                                   NJ 07677.
ANDA 076372............  Brimonidine Tartrate     Teva Parenteral
                          Ophthalmic Solution,     Medicines, Inc.
                          0.2%.
ANDA 076398............  Tamoxifen Citrate        Aegis Pharmaceuticals
                          Tablets USP, 10 mg and   PLC, c/o GlobePharm
                          20 mg.                   Inc., 313 Pine St.,
                                                   Suite 204, Deerfield,
                                                   IL 60015.
ANDA 076424............  Fluconazole Tablets, 50  Pliva Inc., c/o Barr
                          mg, 100 mg, 150 mg,      Laboratories Inc., an
                          and 200 mg.              indirect, wholly
                                                   owned subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, U.S. Agent, 400
                                                   Chestnut Ridge Rd.,
                                                   Woodcliff Lake, NJ
                                                   07677.
ANDA 076448............  Topiramate Capsules, 15  Barr Laboratories,
                          mg and 25 mg.            Inc.
ANDA 076529............  Loratadine Syrup         Ranbaxy Laboratories
                          (loratadine oral         Limited, c/o Ranbaxy
                          solution USP), 1 mg/mL.  Inc., U.S., 600
                                                   College Rd. East,
                                                   Princeton, NJ 08540.
ANDA 076540............  Sertraline HCl Tablets,  Mylan Pharmaceuticals,
                          25 mg, 50 mg, and 100    Inc.
                          mg.
ANDA 076612............  Benazepril HCl and       Do.
                          Hydrochlorothiazide
                          Tablets, 5 mg/6.25 mg,
                          10 mg/12.5 mg, 20 mg/
                          12.5 mg, and 20 mg/25
                          mg.
ANDA 076640............  Metoprolol Succinate     Nesher Pharmaceuticals
                          Extended-Release         (USA) LLC.
                          Tablets, 100 mg and
                          200 mg.
ANDA 076865............  Fluticasone Proprionate  Do.
                          Cream, 0.05%.
ANDA 076982............  Prednisolone Sodium      Do.
                          Phosphate Oral
                          Solution USP, 5 mg/5
                          mL.
ANDA 076992............  Ciprofloxacin Injection  Bedford Laboratories.
                          USP, 10 mg/mL.
ANDA 076993............  Ciprofloxacin Injection  Do.
                          USP, 10 mg/mL.
ANDA 077074............  Lorazepam Injection USP  Do.
                          (Preservative-Free), 2
                          mg/mL and 4 mg/mL.
ANDA 077076............  Lorazepam Injection      Do.
                          USP, 2 mg/mL and 4 mg/
                          mL, 10 mL per vial.
ANDA 077080............  Amlodipine Besylate      Synthon
                          Tablets, 2.5 mg, 5 mg,   Pharmaceuticals,
                          and 10 mg.               Inc., 9000
                                                   Development Dr., P.O.
                                                   Box 110487, Research
                                                   Triangle Park, NC
                                                   27709.
ANDA 077085............  Leflunomide Tablets, 10  Sandoz Inc.
                          mg and 20 mg.
ANDA 077311............  Hydromorphone HCl        Nesher Pharmaceuticals
                          Tablets USP, 2 mg, 4     (USA) LLC.
                          mg, and 8 mg.
ANDA 085917............  Acetaminophen and        Sandoz Inc.
                          Codeine Phosphate
                          Tablets, 30 mg.
ANDA 087423............  Acetaminophen and        Do.
                          Codeine Phosphate
                          Tablets, 300 mg/60 mg.
ANDA 087433............  Acetaminophen and        Do.
                          Codeine Phosphate
                          Tablets, 300 mg/15 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 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.

    Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09124 Filed 4-21-14; 8:45 am]
BILLING CODE 4160-01-P