Document ID: FDA-2018-N-3569-0001
Agency: fda
Document Type: Notice
Title: GlaxoSmithKline, LLC, et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications
Posted Date: 2018-09-28T04:00Z

[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49102-49103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21199]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3569]

GlaxoSmithKline, LLC, et al.; Withdrawal of Approval of 24 
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 24 abbreviated new drug applications (ANDAs) 
from multiple applicants. The applicants 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of October 29, 2018.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, 
[email protected].

SUPPLEMENTARY INFORMATION: The applicants listed in the table have 
informed FDA that these drug products are no longer marketed and have 
requested that FDA withdraw approval of the applications under the 
process described 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.

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
ANDA 061336............  Bactocill (oxacillin     GlaxoSmithKline, LLC,
                          sodium) Capsules,        Five Moore Dr., P.O.
                          Equivalent to (EQ) 250   Box 13398, Research
                          milligrams (mg) base     Triangle Park, NC
                          and EQ 500 mg base.      27709.
ANDA 061773............  Kefzol (cefazolin) for   ACS Dobfar S.p.A., c/o
                          Injection USP, EQ 250    Interchem Corp., 120
                          mg base/vial, EQ 500     Rte. 17 North,
                          mg base/vial, EQ 1       Paramus, NJ 07652.
                          gram (g) base/vial, EQ
                          10 g base/vial, and EQ
                          20 g base/vial.
ANDA 062615............  Nystatin Vaginal         Odyssey
                          Inserts USP, 100,000     Pharmaceuticals,
                          units.                   Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
ANDA 063304............  Clindamycin Phosphate    Wockhardt Bio AG, c/o
                          Topical Solution USP,    Morton Grove
                          EQ 1% base.              Pharmaceuticals,
                                                   Inc., 6451 Main St.,
                                                   Morton Grove, IL
                                                   60053.
ANDA 065001............  Cefuroxime for           Fresenius Kabi USA,
                          Injection USP, EQ        LLC, Three Corporate
                          750mg base/vial and EQ   Dr., Lake Zurich, IL
                          1.5 g base/vial.         60047.
ANDA 065002............  Cefuroxime for           Do.
                          Injection USP, EQ 7.5
                          g base/vial (Pharmacy
                          Bulk Package).
ANDA 070736............  Ibuprofen Tablets USP,   Aurolife Pharma, LLC,
                          300 mg, 400 mg, and      279 Princeton
                          600 mg.                  Hightstown Rd., East
                                                   Windsor, NJ 08520.
ANDA 071202............  Sensorcaine--MPF Spinal  Fresenius Kabi USA,
                          (bupivacaine             LLC.
                          hydrochloride (HCl))
                          in Dextrose Injection
                          8.25% USP, 0.75%.
ANDA 071846............  Nitroglycerin in         Hospira, Inc., 275
                          Dextrose 5% Injection,   North Field Dr.,
                          10 mg/100 milliliter     Bldg. H1, Lake
                          (mL).                    Forest, IL 60045.
ANDA 071847............  Nitroglycerin in         Do.
                          Dextrose 5% Injection,
                          20 mg/100 mL.
ANDA 071848............  Nitroglycerin in         Do.
                          Dextrose 5% Injection,
                          40 mg/100 mL.
ANDA 072629............  Albuterol Tablets USP,   Watson Laboratories,
                          EQ 2 mg base.            Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
ANDA 074991............  Loperamide HCl Oral      Duramed
                          Solution, 1 mg/5 mL.     Pharmaceuticals,
                                                   Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.

[[Page 49103]]

 
ANDA 077312............  Fentanyl Citrate Troche/ Par Pharmaceutical,
                          Lozenge, EQ 0.2 mg       Inc., One Ram Ridge
                          base, EQ 0.4 mg base,    Rd., Chestnut Ridge,
                          EQ 0.6 mg base, EQ 0.8   NY 10977.
                          mg base, EQ 1.2 mg,
                          and EQ 1.6 mg base.
ANDA 077853............  Metformin HCl Tablets    Provident
                          USP, 500 mg, 850 mg,     Pharmaceutical, Inc.,
                          and 1 g.                 c/o Vintage
                                                   Pharmaceuticals, LLC,
                                                   1400 Atwater Dr.,
                                                   Malvern, PA 19355.
ANDA 080355............  Hydrocortisone Tablets   Watson Laboratories,
                          USP, 20 mg.              Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc., Morris
                                                   Corporate Center III,
                                                   400 Interpace Pkwy.,
                                                   Parsippany, NJ 07054.
ANDA 080377............  Lidocaine HCl with       Watson Laboratories,
                          Epinephrine Injection,   Inc., Subsidiary of
                          1%; 0.01 mg/mL and 2%;   Teva Pharmaceuticals
                          0.01 mg/mL.              USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
ANDA 087100............  Chlorthalidone Tablets   Do.
                          USP, 25 mg.
ANDA 087211............  Methocarbamol and        Ivax Pharmaceuticals,
                          Aspirin Tablets, 400     Inc., Subsidiary of
                          mg/325 mg.               Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
ANDA 090184............  Podofilox Topical        Bausch & Lomb, Inc.,
                          Solution, 0.5%.          Subsidiary of Valeant
                                                   Pharmaceuticals North
                                                   America, LLC, 400
                                                   Somerset Corporate
                                                   Blvd., Bridgewater,
                                                   NJ 08807.
ANDA 202002............  Imiquimod Cream, 5%....  Strides Pharma Global
                                                   Pte Ltd., c/o Strides
                                                   Pharma, Inc., 2 Tower
                                                   Center Blvd., Suite
                                                   1102, East Brunswick,
                                                   NJ 08816.
ANDA 203247............  Sodium Fluoride F-18     University of Texas MD
                          Injection, 10-200        Anderson Cancer
                          millicurie (mCi)/mL.     Center, Cyclotron
                                                   Radiochemistry
                                                   Facility, 1881 East
                                                   Rd., Unit 1903,
                                                   Houston, TX 77054.
ANDA 203933............  Ammonia N-13 Injection,  Do.
                          3.75-37.5 mCi/mL.
ANDA 205072............  Cefadroxil Capsules      CSPC Ouyi
                          USP, EQ 500 mg base.     Pharmaceutical Co.,
                                                   Ltd., c/o Megalith
                                                   Pharmaceuticals,
                                                   Inc., 9625 Hillside
                                                   Rd., Rancho
                                                   Cucamonga, CA 91737.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
October 29, 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 the 
table that are in inventory on October 29, 2018 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: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21199 Filed 9-27-18; 8:45 am]
 BILLING CODE 4164-01-P