Document ID: FDA-2017-N-6591-0001
Agency: fda
Document Type: Notice
Title: Barr Laboratories, Inc. et al.; Withdrawal of Approval of 68 Abbreviated New Drug Applications
Posted Date: 2017-12-01T05:00Z

[Federal Register Volume 82, Number 230 (Friday, December 1, 2017)]
[Notices]
[Pages 56976-56978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25920]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6591]

Barr Laboratories, Inc. et al.; Withdrawal of Approval of 68 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of 68 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requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of January 2, 2018.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945.

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 040135...............  Estropipate Tablets    Barr Laboratories,
                             USP, 0.75 milligrams   Inc., Subsidiary of
                             (mg), 1.5 mg, and 3    Teva Pharmaceuticals
                             mg.                    USA, Inc., 425
                                                    Privet Rd., Horsham,
                                                    PA 19044.
ANDA 040755...............  Carisoprodol Tablets   Sun Pharmaceutical
                             USP, 350 mg.           Industries, Ltd., c/
                                                    o Sun Pharmaceutical
                                                    Industries, Inc.,
                                                    270 Prospect Plains
                                                    Rd., Cranbury, NJ
                                                    08512.

[[Page 56977]]

 
ANDA 062588...............  Gentamicin Sulfate in  Hospira, Inc., a
                             0.9% Sodium Chloride   Pfizer Company, 275
                             Injection,             North Field Dr.,
                             Equivalent to (EQ)     Bldg. H1, Lake
                             1.2 mg base/           Forest, IL 60045.
                             milliliter (mL), EQ
                             1.4 mg base/mL, EQ
                             1.6 mg base/mL, EQ
                             1.8 mg base/mL, EQ 2
                             mg base/mL, EQ 60 mg
                             base/100 mL, EQ 70
                             mg base/100 mL, EQ
                             80 mg base/100 mL,
                             EQ 90 mg base/100
                             mL, and EQ 100 mg
                             base/100 mL.
ANDA 062591...............  Kefurox (cefuroxime)   ACS Dobfar S.p.A., c/
                             for Injection USP,     o Interchem Corp.,
                             EQ 750 mg base/vial,   120 Route 17 North,
                             EQ 1.5 grams (g)       Paramus, NJ 07652.
                             base/vial, and EQ
                             7.5 g base/vial.
ANDA 062756...............  Primaxin IV (imipenem  Merck Sharp & Dohme
                             and cilastatin) for    Corp., Subsidiary of
                             Injection USP, 250     Merck & Co., Inc., 1
                             mg/vial; EQ 250 mg     Merck Dr., P.O. Box
                             base/vial and 500 mg/  100, Whitehouse
                             vial; EQ 500 mg base/  Station, NJ 08889.
                             vial.
ANDA 063207...............  Cefazolin for          Facta Farmaceutici
                             Injection USP, EQ 1    S.p.A., c/o
                             g base/vial.           Interchem Corp., 120
                                                    Route 17 North,
                                                    Suite 115, Paramus,
                                                    NJ 07652.
ANDA 063209...............  Cefazolin for          Do.
                             Injection USP, EQ 10
                             g base/vial and EQ
                             20 g base/vial
                             (Pharmacy Bulk
                             Package).
ANDA 063214...............  Cefazolin for          Do.
                             Injection USP, EQ
                             500 mg base/vial.
ANDA 063263...............  Amikacin Sulfate       Hospira, Inc.
                             Injection USP, EQ 50
                             mg base/mL.
ANDA 065268...............  Ceftriaxone for        Facta Farmaceutici
                             Injection USP, EQ 1    S.p.A.
                             g base/vial and EQ 2
                             g base/vial.
ANDA 065269...............  Ceftriaxone for        Do.
                             Injection USP, EQ 10
                             g base/vial
                             (Pharmacy Bulk
                             Package).
ANDA 065348...............  Cefotaxime for         Cephazone Pharma,
                             Injection USP, EQ 10   LLC, 250 E. Bonita
                             g base/vial            Ave., Pomona, CA
                             (Pharmacy Bulk         91767.
                             Package).
ANDA 065464...............  Cefoxitin for          ACS Dobfar S.p.A.
                             Injection USP, EQ 10
                             g base/vial
                             (Pharmacy Bulk
                             Package).
ANDA 065467...............  Cefoxitin for          Do.
                             Injection USP, EQ 1
                             g base/vial and EQ 2
                             g base/vial.
ANDA 070048...............  Cotrim D.S.            Teva Pharmaceuticals
                             (sulfamethoxazole      USA, Inc., 425
                             and trimethoprim)      Privet Rd., Horsham,
                             Tablets USP, 800 mg/   PA 19044.
                             160 mg.
ANDA 070195...............  Valproic Acid          Catalent Pharma
                             Capsules USP, 250 mg.  Solutions, LLC, 2725
                                                    Scherer Dr. North,
                                                    St. Petersburg, FL
                                                    33716.
ANDA 070513...............  Tolazamide Tablets     Watson Laboratories,
                             USP, 100 mg.           Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, Inc., 425
                                                    Privet Rd., Horsham,
                                                    PA 19044.
ANDA 070514...............  Tolazamide Tablets     Do.
                             USP, 250 mg.
ANDA 071358...............  Tolazamide Tablets     Sun Pharmaceutical
                             USP, 250 mg.           Industries, Inc.,
                                                    270 Prospect Plains
                                                    Rd., Cranbury, NJ
                                                    08512.
ANDA 071359...............  Tolazamide Tablets     Do.
                             USP, 500 mg.
ANDA 071667...............  Ibuprofen Tablets      Pliva, Inc.,
                             USP, 600 mg.           Subsidiary of Teva
                                                    Pharmaceuticals USA,
                                                    Inc., 425 Privet
                                                    Rd., Horsham, PA
                                                    19044.
ANDA 071668...............  Ibuprofen Tablets      Do.
                             USP, 800 mg.
ANDA 071735...............  Ibuprofen Tablets      Contract Pharmacal
                             USP, 200 mg.           Corp., c/o SciRegs
                                                    International Inc.,
                                                    6333 Summercrest
                                                    Dr., Columbia, MD
                                                    21045.
ANDA 071773...............  Ibuprofen Tablets      Pliva, Inc.,
                             USP, 200 mg.           Subsidiary of Teva
                                                    Pharmaceuticals USA,
                                                    Inc.
ANDA 073254...............  Loperamide             Contract Pharmacal
                             Hydrochloride (HCl)    Corp.
                             Tablets USP, 2 mg.
ANDA 074075...............  Clemastine Fumarate    Actavis Mid Atlantic,
                             Syrup, EQ 0.5 mg       LLC, Subsidiary of
                             base/5 mL.             Teva Pharmaceuticals
                                                    USA, Inc., 425
                                                    Privet Rd., Horsham,
                                                    PA 19044.
ANDA 074536...............  Haloperidol Oral       Do.
                             Solution USP, EQ 1
                             mg base/mL.
ANDA 074782...............  Ibuprofen Capsules,    Contract Pharmacal
                             200 mg.                Corp.
ANDA 074789...............  Naproxen Sodium        Do.
                             Tablets USP, EQ 200
                             mg base.
ANDA 074931...............  Ibuprofen Tablets      Do.
                             USP, 200 mg.
ANDA 074961...............  Cimetidine Tablets     Do.
                             USP, 200 mg.
ANDA 074963...............  Cimetidine Tablets     Do.
                             USP, 200 mg.
ANDA 075094...............  Ranitidine Tablets     Do.
                             USP, EQ 75 mg base.
ANDA 075588...............  Ibuprofen and          Do.
                             Pseudoephedrine HCl
                             Tablets USP, 200 mg/
                             30 mg.
ANDA 077058...............  Pantoprazole Sodium    Sun Pharmaceutical
                             Delayed-Release        Industries, Ltd.
                             Tablets USP, EQ 20
                             mg base and EQ 40 mg
                             base.
ANDA 077172...............  Ondansetron Injection  Do.
                             USP, EQ 2 mg base/mL.
ANDA 077329...............  Octreotide Acetate     Do.
                             Injection, EQ 0.05
                             mg base/mL, EQ 0.1
                             mg base/mL, and EQ
                             0.5 mg base/mL.
ANDA 077330...............  Octreotide Acetate     Do.
                             Injection, EQ 0.2 mg
                             base/mL.
ANDA 077331...............  Octreotide Acetate     Do.
                             Injection, EQ 1 mg
                             base/mL.
ANDA 078108...............  Sertraline HCl         Do.
                             Tablets, EQ 25 mg
                             base, EQ 50 mg base,
                             and EQ 100 mg base.
ANDA 078478...............  Torsemide Tablets, 5   Do.
                             mg, 10 mg, 20 mg,
                             and 100 mg.
ANDA 083000...............  Folic Acid Tablets, 1  Ivax Pharmaceutical
                             mg.                    USA, Inc.,
                                                    Subsidiary of Teva
                                                    Pharmaceuticals USA,
                                                    Inc., 425 Privet
                                                    Rd., Horsham, PA
                                                    19044.
ANDA 085549...............  Reserpine,             Watson Laboratories,
                             Hydralazine HCl, and   Inc., Subsidiary of
                             Hydrochlorothiazide    Teva Pharmaceuticals
                             Tablets, 0.1 mg/25     USA, Inc.
                             mg/15 mg.
ANDA 086109...............  Tolbutamide Tablets    Do.
                             USP, 500 mg.
ANDA 086577...............  Trimethobenzamide HCl  Do.
                             Injection, 100 mg/mL.

[[Page 56978]]

 
ANDA 087191...............  Triamcinolone          Alpharma U.S. Pharms,
                             Acetonide Lotion       Subsidiary of Teva
                             USP, 0.025%.           Pharmaceuticals USA,
                                                    Inc., 425 Privet
                                                    Rd., Horsham, PA
                                                    19044.
ANDA 087398...............  Spironolactone and     Watson Laboratories,
                             Hydrochlorothiazide    Inc., Subsidiary of
                             Tablets USP, 25 mg/    Teva Pharmaceuticals
                             25 mg.                 USA, Inc.
ANDA 088229...............  Thioridazine HCl Oral  Actavis Mid Atlantic,
                             Solution USP, 100 mg/  LLC, Subsidiary of
                             mL.                    Teva Pharmaceuticals
                                                    USA, Inc.
ANDA 088563...............  Thioridazine HCl       Watson Laboratories,
                             Tablets USP, 50 mg.    Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, Inc.
ANDA 088567...............  Thioridazine HCl       Do.
                             Tablets USP, 25 mg.
ANDA 088733...............  Meclizine HCl          Pliva, Inc.,
                             Tablets, 25 mg         Subsidiary of Teva
                             (Chewable).            Pharmaceuticals USA,
                                                    Inc.
ANDA 088869...............  Thioridazine HCl       Watson Laboratories,
                             Tablets USP, 150 mg.   Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, Inc.
ANDA 090800...............  Quinapril Tablets      Sun Pharmaceutical
                             USP, EQ 5 mg base,     Industries, Ltd.
                             EQ 10 mg base, EQ 20
                             mg base, and EQ 40
                             mg base.
ANDA 091177...............  Anastrozole Tablets,   Do.
                             1 mg.
ANDA 091466...............  Letrozole Tablets      Do.
                             USP, 2.5 mg.
ANDA 200486...............  Norethindrone and      Mylan Laboratories,
                             Ethinyl Estradiol      Ltd., c/o Mylan
                             Tablets USP, 0.5 mg/   Pharmaceuticals,
                             0.035 mg, 0.75 mg/     Inc., 781 Chestnut
                             0.035 mg, and 1 mg/    Ridge Rd., P.O. Box
                             0.035 mg.              4310, Morgantown, WV
                                                    26504.
ANDA 200488...............  Norethindrone and      Do.
                             Ethinyl Estradiol
                             Tablets USP, 0.5 mg/
                             0.035 mg.
ANDA 200489...............  Norethindrone and      Do.
                             Ethinyl Estradiol
                             Tablets USP, 1 mg/
                             0.035 mg.
ANDA 201250...............  Vancomycin HCl for     Teva Pharmaceuticals
                             Injection USP, EQ 5    USA, Inc.
                             g base/vial and EQ
                             10 g base/vial
                             (Pharmacy Bulk
                             Package).
ANDA 201251...............  Vancomycin HCl for     Do.
                             Injection USP, EQ
                             500 mg base/vial and
                             EQ 1 g base/vial.
ANDA 201828...............  Norgestrel and         Mylan Laboratories,
                             Ethinyl Estradiol      Ltd.
                             Tablets USP, 0.3 mg/
                             0.03 mg.
ANDA 202203...............  Topotecan HCl for      Sun Pharmaceutical
                             Injection, EQ 4 mg     Industries, Ltd.
                             base/vial.
ANDA 202746...............  Zoledronic Acid        Sun Pharma Global
                             Injection, EQ 4 mg     FZE, c/o Sun
                             base/5 mL.             Pharmaceutical
                                                    Industries, Inc., 2
                                                    Independence Way,
                                                    Princeton, NJ 08540.
ANDA 202875...............  Norgestrel and         Mylan Laboratories,
                             Ethinyl Estradiol      Ltd.
                             Tablets USP, 0.5 mg/
                             0.05 mg.
ANDA 203476...............  Zolmitriptan Tablets,  Sun Pharma Global
                             2.5 mg and 5 mg.       FZE.
ANDA 203685...............  Irbesartan Tablets     Ajanta Pharma Ltd., c/
                             USP, 75 mg, 150 mg,    o Ajanta Pharma USA,
                             and 300 mg.            Inc., One Grande
                                                    Commons, 440 US
                                                    Highway 22 East,
                                                    Suite 150,
                                                    Bridgewater, NJ
                                                    08807.
ANDA 203838...............  Hydrocodone            Tris Pharma, Inc.,
                             Bitartrate,            2033 Route 130,
                             Chlorpheniramine       Monmouth Junction,
                             Maleate, and           NJ 08852.
                             Pseudoephedrine HCl
                             Oral Solution, 5 mg/
                             4 mg/60 mg per 5 mL.
ANDA 203839...............  Hydrocodone            Do.
                             Bitartrate and
                             Pseudoephedrine HCl
                             Oral Solution, 5 mg/
                             60 mg per 5 mL.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in table 1 of this 
document, and all amendments and supplements thereto, is hereby 
withdrawn as of January 2, 2018. Introduction or delivery for 
introduction into interstate commerce of products without approved new 
drug applications violates section 301(a) and (d) of the Federal Food, 
Drug, and Cosmetic 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: November 27, 2017.
Leslie Kux,
Associate Commissioner for Policy..
[FR Doc. 2017-25920 Filed 11-30-17; 8:45 am]
 BILLING CODE 4164-01-P