Allergan, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications, 76849 [2024-21432]
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Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices
www.healthaffairs.org/doi/full/10.1377/
hlthaff.25.2.313.
Silver Spring, MD 20993–0002, 301–
796–3471, Martha.Nguyen@fda.hhs.gov.
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of nine
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withdrawn.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
SUMMARY:
[FR Doc. 2024–21433 Filed 9–18–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Approval is withdrawn as of
October 21, 2024.
DATES:
[Docket No. FDA–2024–N–4289]
Allergan, Inc., et al.; Withdrawal of
Approval of Nine Abbreviated New
Drug Applications
AGENCY:
ACTION:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration,
HHS.
76849
The
applicants listed in table 1 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
§ 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.
SUPPLEMENTARY INFORMATION:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
TABLE 1—ANDAS FOR WHICH APPROVAL IS WITHDRAWN
Application No.
Drug
Applicant
ANDA 062452 ....
Gentamicin Sulfate solution/drop, Equivalent to (EQ) 0.3%
base.
Cefuroxime Sodium injectable, EQ 7.5 grams (g) base/vial ...
Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA
92612.
ACS Dobfar S.p.A., U.S. Agent Interchem Corp., 120 Route
17 North, Paramus, NJ 07652.
Woodward Pharma Services, LLC, 47220 Cartier Dr., Suite
A, Wixom, MI 48393.
ANDA 064124 ....
ANDA 077151 ....
ANDA 079032 ....
ANDA 079075 ....
ANDA 206155 ....
Olanzapine tablet, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and
20 mg.
ANDA 206204 ....
Piperacillin Sodium and Tazobactam Sodium injectable, EQ
12 gm base/vial, EQ 1.5 gm base/vial.
Acyclovir Sodium injectable, EQ 50 mg base/mL ...................
ANDA 207919 ....
ANDA 209708 ....
lotter on DSK11XQN23PROD with NOTICES1
Milrinone Lactate injectable, EQ 40 milligrams (mg) base/200
milliliters (mL) (EQ 0.2 mg base/mL) EQ 20 mg base/100
mL (EQ 0.2 mg base/mL).
Ondansetron Hydrochloride preservative free injectable, EQ
2 mg base/mL.
Fentanyl Citrate tablet, EQ 0.1 mg base, EQ 0.2 mg base,
EQ 0.4 mg base, EQ 0.6 mg base, and EQ 0.8 mg base.
Mivacurium Chloride solution, EQ 10 mg base/5 mL (EQ 2
mg base/mL) and EQ 20 mg base/10 mL (EQ 2 mg base/
mL).
Therefore, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn as of October 21,
2024. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from table 1.
Introduction or delivery for introduction
into interstate commerce of products
listed in table 1 without an approved
new drug application or ANDA violates
sections 505(a) and 301(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)). Drug products that
are listed in table 1 that are in inventory
on October 21, 2024 may continue to be
dispensed until the inventories have
been depleted or the drug products have
reached their expiration dates or
VerDate Sep<11>2014
16:59 Sep 18, 2024
Jkt 262001
American Regent, Inc., 5 Ramsey Rd., Shirley, NY 11967.
Watson Laboratories, Inc., (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace
Pkwy., Bldg. A, Parsippany, NJ 07054.
Indoco Remedies Ltd., U.S. Agent RegCon Solutions, LLC,
9920 Pacific Heights Blvd., Suite 250, San Diego, CA
92121.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich,
IL 60047.
Dr. Reddy’s Laboratories, Inc., 107 College Rd. East, Princeton, NJ 08540.
Woodward Pharma Services, LLC.
otherwise become violative, whichever
occurs first.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21432 Filed 9–18–24; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4189]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments: Strain
Selection for Influenza Vaccines
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Vaccines and Related
SUMMARY:
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]]>Agencies
[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Page 76849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21432]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4289]
Allergan, Inc., et al.; Withdrawal of Approval of Nine
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 nine 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 21, 2024.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 301-
796-3471, [email protected].
SUPPLEMENTARY INFORMATION: The applicants listed in table 1 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--ANDAs for Which Approval Is Withdrawn
----------------------------------------------------------------------------------------------------------------
Application No. Drug Applicant
----------------------------------------------------------------------------------------------------------------
ANDA 062452................. Gentamicin Sulfate solution/drop, Allergan, Inc., 2525 Dupont Dr., P.O.
Equivalent to (EQ) 0.3% base. Box 19534, Irvine, CA 92612.
ANDA 064124................. Cefuroxime Sodium injectable, EQ 7.5 ACS Dobfar S.p.A., U.S. Agent Interchem
grams (g) base/vial. Corp., 120 Route 17 North, Paramus, NJ
07652.
ANDA 077151................. Milrinone Lactate injectable, EQ 40 Woodward Pharma Services, LLC, 47220
milligrams (mg) base/200 milliliters Cartier Dr., Suite A, Wixom, MI 48393.
(mL) (EQ 0.2 mg base/mL) EQ 20 mg base/
100 mL (EQ 0.2 mg base/mL).
ANDA 079032................. Ondansetron Hydrochloride preservative American Regent, Inc., 5 Ramsey Rd.,
free injectable, EQ 2 mg base/mL. Shirley, NY 11967.
ANDA 079075................. Fentanyl Citrate tablet, EQ 0.1 mg base, Watson Laboratories, Inc., (an indirect,
EQ 0.2 mg base, EQ 0.4 mg base, EQ 0.6 wholly owned subsidiary of Teva
mg base, and EQ 0.8 mg base. Pharmaceuticals USA, Inc.), 400
Interpace Pkwy., Bldg. A, Parsippany,
NJ 07054.
ANDA 206155................. Olanzapine tablet, 2.5 mg, 5 mg, 7.5 mg, Indoco Remedies Ltd., U.S. Agent RegCon
10 mg, 15 mg, and 20 mg. Solutions, LLC, 9920 Pacific Heights
Blvd., Suite 250, San Diego, CA 92121.
ANDA 206204................. Piperacillin Sodium and Tazobactam Fresenius Kabi USA, LLC, Three Corporate
Sodium injectable, EQ 12 gm base/vial, Dr., Lake Zurich, IL 60047.
EQ 1.5 gm base/vial.
ANDA 207919................. Acyclovir Sodium injectable, EQ 50 mg Dr. Reddy's Laboratories, Inc., 107
base/mL. College Rd. East, Princeton, NJ 08540.
ANDA 209708................. Mivacurium Chloride solution, EQ 10 mg Woodward Pharma Services, LLC.
base/5 mL (EQ 2 mg base/mL) and EQ 20
mg base/10 mL (EQ 2 mg base/mL).
----------------------------------------------------------------------------------------------------------------
Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of October
21, 2024. Approval of each entire application is withdrawn, including
any strengths and dosage forms inadvertently missing from table 1.
Introduction or delivery for introduction into interstate commerce of
products listed in table 1 without an approved new drug application or
ANDA violates sections 505(a) and 301(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are
listed in table 1 that are in inventory on October 21, 2024 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 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21432 Filed 9-18-24; 8:45 am]
BILLING CODE 4164-01-P
