Document ID: FDA-2019-N-0163-0002
Agency: fda
Document Type: Notice
Title: Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug
Applications
Posted Date: 2019-06-14T04:00Z

[Federal Register Volume 84, Number 115 (Friday, June 14, 2019)]
[Notices]
[Page 27788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12560]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0163]

Hospira, Inc., et al.; Withdrawal of Approval of 12 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 12 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of July 15, 2019.

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, 
Trang.Tran@fda.hhs.gov.

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 040664...............  A-Methapred            Hospira, Inc., 275
                             (methylprednisolone    North Field Dr.,
                             sodium succinate)      Building H1, Lake
                             for Injection USP,     Forest, IL 60045.
                             Equivalent to (EQ)
                             40 milligrams (mg)
                             base/vial.
ANDA 040665...............  A-Methapred            Do.
                             (methylprednisolone
                             sodium succinate)
                             for Injection USP,
                             EQ 125 mg base/vial.
ANDA 060462...............  Garamycin (gentamicin  Schering Corp., 2000
                             sulfate) Cream USP,    Galloping Hill Rd.,
                             EQ 0.1% base.          Kenilworth, NJ
                                                    07033.
ANDA 061533...............  Mycostatin (nystatin)  Bristol-Myers Squibb
                             Oral Suspension USP,   Co., P.O. Box 4500,
                             100,000 units/         Princeton, NJ 08543.
                             milliliter (mL).
ANDA 071051...............  Astramorph/PF          Fresenius Kabi USA,
                             (morphine sulfate)     LLC, Three Corporate
                             Injection USP, 0.5     Dr., Lake Zurich, IL
                             mg/mL.                 60047.
ANDA 071052...............  Astramorph/PF          Do.
                             (morphine sulfate)
                             Injection USP, 1 mg/
                             mL.
ANDA 071053...............  Astramorph/PF          Do.
                             (morphine sulfate)
                             Injection USP, 1 mg/
                             mL.
ANDA 075656...............  Morphine Sulfate       Watson Laboratories,
                             Extended-Release       Inc., Subsidiary of
                             Tablets, 100 mg.       Teva Pharmaceuticals
                                                    USA, Inc., 425
                                                    Privet Rd., Horsham,
                                                    PA 19044.
ANDA 078815...............  Oxaliplatin for        Hospira, Inc.
                             Injection, 50 mg/
                             vial and 100 mg/vial.
ANDA 088119...............  Isoniazid Tablets      Duramed
                             USP, 300 mg.           Pharmaceuticals,
                                                    Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, Inc., 400
                                                    Interpace Pky.,
                                                    Morris Corporate
                                                    Center III,
                                                    Parsippany, NJ
                                                    07054.
ANDA 088231...............  Isoniazid Tablets      Do.
                             USP, 100 mg.
ANDA 091597...............  Gemcitabine for        Sagent
                             Injection USP, EQ      Pharmaceuticals,
                             200 mg base/vial and   Inc., 1901 North
                             EQ 1 gram base/vial.   Roselle Rd., Suite
                                                    450, Schaumburg, IL
                                                    60195.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of July 
15, 2019. Approval of each entire application is withdrawn, including 
any strengths or products inadvertently missing from the table. 
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 July 15, 2019, 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 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12560 Filed 6-13-19; 8:45 am]
 BILLING CODE 4164-01-P