Notice2026-08020
Egis Pharmaceuticals Limited, et al.; Withdrawal of Approval of Three Abbreviated New Drug Applications
Primary source
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Published
April 24, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of three abbreviated new drug applications (ANDAs) from the holders of those ANDAs. The basis for the withdrawal is that the ANDA holders have repeatedly failed to file required annual reports for those ANDAs.
Full Text
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<title>Federal Register, Volume 91 Issue 79 (Friday, April 24, 2026)</title>
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[Federal Register Volume 91, Number 79 (Friday, April 24, 2026)]
[Notices]
[Pages 22156-22157]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08020]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[FDA-2026-N-3445]
Egis Pharmaceuticals Limited, et al.; Withdrawal of Approval of
Three 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 three abbreviated new drug applications (ANDAs)
from the holders of those ANDAs. The basis for the withdrawal is that
the ANDA holders have repeatedly failed to file required annual reports
for those ANDAs.
DATES: Approval is withdrawn as of April 24, 2026.
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, <a href="/cdn-cgi/l/email-protection#7b361a090f131a55351c0e021e153b1d1f1a55131308551c140d"><span class="__cf_email__" data-cfemail="b2ffd3c0c6dad39cfcd5c7cbd7dcf2d4d6d39cdadac19cd5ddc4">[email protected]</span></a>.
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 December 29, 2025 (90 FR 60724), FDA
published a notice offering an opportunity for a hearing (NOOH) on a
proposal to withdraw approval of three ANDAs because the holders of
these ANDAs had repeatedly failed to submit the required annual reports
for these ANDAs. The holders 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 holders 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
[[Page 22157]]
of the three 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 060453............... Bacitracin-neomycin Ambix Laboratories,
sulfate-polymyxin B 55 West End Rd.,
sulfate ointment Totowa, NJ 07512.
with diperodon
hydrochloride.
ANDA 074748............... Captopril tablet, Egis Pharmaceuticals
12.5 milligrams Ltd., 1475 Budapest
(mg), 25 mg, 50 mg, 10 Pf. 100 Hungary.
and 100 mg.
ANDA 074808............... Piroxicam capsule, 10 Do.
mg and 20 mg.
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FDA finds that the holders of the ANDAs listed in Table 1 have
repeatedly failed to submit reports required by Sec. Sec. 314.81 and
314.98. In addition, under Sec. 314.200, FDA finds that the holders of
the ANDAs have waived the 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 April 24, 2026.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-08020 Filed 4-23-26; 8:45 am]
BILLING CODE 4164-01-P
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