[Federal Register Volume 89, Number 104 (Wednesday, May 29, 2024)]
[Notices]
[Page 46406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of June 28, 2024.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, [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              Table 1--NDAs for Which Approval Is Withdrawn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]
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