Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications, 27788 [2019-12560]
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Federal Register / Vol. 84, No. 115 / Friday, June 14, 2019 / Notices
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[FR Doc. 2019–12566 Filed 6–13–19; 8:45 am]
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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.
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
SUMMARY:
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applications be withdrawn.
DATES: Approval is withdrawn as of July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 § 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
§ 314.150(c) is without prejudice to
refiling.
Application No.
Drug
Applicant
ANDA 040664 .........
Hospira, Inc., 275 North Field Dr., Building H1, Lake Forest, IL 60045.
ANDA 071052 .........
ANDA 071053 .........
ANDA 075656 .........
A-Methapred (methylprednisolone sodium succinate) for Injection USP, Equivalent to (EQ) 40 milligrams (mg) base/
vial.
A-Methapred (methylprednisolone sodium succinate) for Injection USP, EQ 125 mg base/vial.
Garamycin (gentamicin sulfate) Cream USP, EQ 0.1%
base.
Mycostatin (nystatin) Oral Suspension USP, 100,000 units/
milliliter (mL).
Astramorph/PF (morphine sulfate) Injection USP, 0.5 mg/
mL.
Astramorph/PF (morphine sulfate) Injection USP, 1 mg/mL
Astramorph/PF (morphine sulfate) Injection USP, 1 mg/mL
Morphine Sulfate Extended-Release Tablets, 100 mg .........
ANDA 078815 .........
ANDA 088119 .........
Oxaliplatin for Injection, 50 mg/vial and 100 mg/vial ............
Isoniazid Tablets USP, 300 mg .............................................
ANDA 088231 .........
ANDA 091597 .........
Isoniazid Tablets USP, 100 mg .............................................
Gemcitabine for Injection USP, EQ 200 mg base/vial and
EQ 1 gram base/vial.
ANDA 040665 .........
ANDA 060462 .........
ANDA 061533 .........
ANDA 071051 .........
jbell on DSK3GLQ082PROD with NOTICES
Dated: June 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
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
VerDate Sep<11>2014
17:04 Jun 13, 2019
Jkt 247001
Do.
Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ
07033.
Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ
08543.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
Do.
Do.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Hospira, Inc.
Duramed Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 400 Interpace Pky., Morris Corporate Center III, Parsippany, NJ 07054.
Do.
Sagent Pharmaceuticals, Inc., 1901 North Roselle Rd.,
Suite 450, Schaumburg, IL 60195.
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[Docket No. FDA–2019–N–2224]
[FR Doc. 2019–12560 Filed 6–13–19; 8:45 am]
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[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
------------------------------------------------------------------------
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
