[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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DATES: Approval is withdrawn as of December 31, 2024.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
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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