[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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of July 15, 2019.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,
[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.
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Application No. Drug Applicant
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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.
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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