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[Federal Register Volume 89, Number 250 (Tuesday, December 31, 2024)]
[Notices]
[Pages 107146-107147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31360]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3271]

Flamingo Pharmaceuticals Ltd.; Withdrawal of Approval of Two 
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 two abbreviated new drug applications (ANDAs) 
from the holder of those ANDAs. The basis for the withdrawal is that 
the ANDA holder has repeatedly failed to file required annual reports 
for those ANDAs.

DATES: Approval is withdrawn as of December 31, 2024.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,

[[Page 107147]]

Silver Spring, MD 20993-0002, 301-796-3471, [email protected].

SUPPLEMENTARY INFORMATION: The holder of an approved application to 
market a new drug for human use is required to submit annual reports to 
FDA concerning its approved application in accordance with Sec. Sec.  
314.81 and 314.98 (21 CFR 314.81 and 314.98).
    In the Federal Register of August 8, 2024 (89 FR 64936), FDA 
published a notice offering an opportunity for a hearing (NOOH) on a 
proposal to withdraw approval of two ANDAs because the holder of these 
ANDAs had repeatedly failed to submit the required annual reports for 
these ANDAs. The holder of these ANDAs did not respond to the NOOH. 
Failure to file a written notice of participation and request for 
hearing as required by Sec.  314.200 (21 CFR 314.200) constitutes a 
waiver of the opportunity for hearing by the holder of the ANDAs 
concerning the proposal to withdraw approval of the ANDAs and a waiver 
of any contentions concerning the legal status of the drug products. 
Therefore, FDA is withdrawing approval of the two applications listed 
in table 1 of this document.

    Table 1--Approved ANDAs for Which Required Reports Have Not Been
                                Submitted
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      Application No.                Drug                Applicant
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ANDA 207309...............  Metronidazole tablet,  Flamingo
                             250 milligrams (mg)    Pharmaceuticals
                             and 500 mg.            Ltd., U.S. Agent for
                                                    Flamingo
                                                    Pharmaceuticals
                                                    Ltd., 1125 Gaither
                                                    Rd., Rockville, MD
                                                    20850.
ANDA 207938...............  Piroxicam capsule, 10  Do.
                             mg and 20 mg.
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    FDA finds that the holder of the ANDAs listed in table 1 has 
repeatedly failed to submit reports required by Sec. Sec.  314.81 and 
314.98. In addition, under Sec.  314.200, FDA finds that the holder of 
the ANDAs has waived its opportunity for a hearing and any contentions 
concerning the legal status of the drug products. Therefore, based on 
these findings and pursuant to the authority under section 505(e) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)), approval 
of the ANDAs listed in table 1 and all amendments and supplements 
thereto, is hereby withdrawn, as of December 31, 2024.

    Dated: December 23, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31360 Filed 12-30-24; 8:45 am]
BILLING CODE 4164-01-P
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