Notice2024-11721
Bayer HealthCare Pharmaceuticals, Inc., et al.; Withdrawal of Approval of Three New Drug Applications
Primary source
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Published
May 29, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of three new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Full Text
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<title>Federal Register, Volume 89 Issue 104 (Wednesday, May 29, 2024)</title>
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[Federal Register Volume 89, Number 104 (Wednesday, May 29, 2024)]
[Notices]
[Page 46406]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-11721]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2377]
Bayer HealthCare Pharmaceuticals, Inc., et al.; Withdrawal of
Approval of Three 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 three new drug applications (NDAs) 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of June 28, 2024.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, <a href="/cdn-cgi/l/email-protection#cc87a5a1aea9bea0b5e280a9a4beaaa9a0a88caaa8ade2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="074c6e6a6562756b7e294b626f7561626b6347616366296f6f7429606871">[email protected]</span></a>.
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--NDAs for Which Approval Is Withdrawn
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Application No. Drug Applicant
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NDA 019857............... Cipro in Dextrose 5% Bayer HealthCare
in Plastic Container Pharmaceuticals,
(ciprofloxacin) Inc., 100 Bayer
Injectable, 200 Blvd., Whippany, NJ
milligrams (mg)/100 07981.
milliliters (mL) and
400 mg/200 mL.
NDA 021158............... Factive (gemifloxacin LG Chem Ltd., C/O
mesylate) Tablet, Parexel
Equivalent to (EQ) International, 2520
320 mg base. Meridian Parkway,
Suite 200, Durham,
NC 27713.
NDA 021473............... Cipro XR Bayer HealthCare
(ciprofloxacin Pharmaceuticals,
hydrochloride) Inc.
Extended-Release
Tablet, EQ 287.5 mg
base.
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Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of June 28,
2024. Approval of each entire application is withdrawn, including any
strengths and dosage forms included in the application but
inadvertently missing from table 1. Introduction or delivery for
introduction into interstate commerce of products listed in table 1
without an approved NDA 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 June
28, 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: May 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11721 Filed 5-28-24; 8:45 am]
BILLING CODE 4164-01-P
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