The eRulemaking Program
04/24/2026 | Press release | Distributed by Public on 04/24/2026 08:48
Withdrawal of Approval of Drug Application: Egis Pharmaceuticals Ltd., et al.
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.
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Approval is withdrawn as of April 24, 2026.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, [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 §§ 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 § 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 of the three 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 060453 | Bacitracin-neomycin sulfate-polymyxin B sulfate ointment with diperodon hydrochloride | Ambix Laboratories, 55 West End Rd., Totowa, NJ 07512. |
| ANDA 074748 | Captopril tablet, 12.5 milligrams (mg), 25 mg, 50 mg, and 100 mg | Egis Pharmaceuticals Ltd., 1475 Budapest 10 Pf. 100 Hungary. |
| ANDA 074808 | Piroxicam capsule, 10 mg and 20 mg | Do. |
FDA finds that the holders of the ANDAs listed in Table 1 have repeatedly failed to submit reports required by §§ 314.81 and 314.98. In addition, under § 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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