# 2025-23870: FDA Revokes Drug Nods Over Egis' Missing Reports

2025-23870, Egis Pharmaceuticals Limited, et.al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications; Opportunity for a Hearing, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-12-29, effective The ANDA holder may submit a request for a hearing by January 28, 2026. Submit all data, information, and analyses upon which the request for a hearing relies by February 27, 2026. Submit electronic or written comments by February 27, 2026. (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-23870
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-23870
- Title: Egis Pharmaceuticals Limited, et.al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications; Opportunity for a Hearing
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 60724
- Published: 2025-12-29
- Effective: The ANDA holder may submit a request for a hearing by January 28, 2026. Submit all data, information, and analyses upon which the request for a hearing relies by February 27, 2026. Submit electronic or written comments by February 27, 2026.
- Comments close: 2026-02-27
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Revokes Drug Nods Over Egis' Missing Reports

## Summary

The FDA wants to take back approval for three drug applications from Egis Pharmaceuticals because they didn’t send in their yearly reports like they were supposed to. Egis and any other holders can ask for a hearing by January 28, 2026, to explain themselves. This could affect the availability of these drugs and might impact the companies financially if approvals are withdrawn.

## Abstract

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of three abbreviated new drug applications (ANDAs) and is announcing an opportunity for the ANDA holders to request a hearing on this proposal. The basis for the proposal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs.

## Effects PRIA read

- ANDA Holders: Hearing Deadline or Waiver: cost, high. If you hold one of the listed ANDAs, you must request a hearing by January 28, 2026 and submit supporting data by February 27, 2026 to challenge FDA's proposal. The FDA proposes to withdraw approval of these ANDAs because the holders repeatedly failed to file required annual reports under 21 CFR 31…
- Possible Removal of Three Generic Drugs: cost, medium. The FDA is proposing to withdraw approval for three ANDAs: ANDA 060453 (bacitracin‑neomycin sulfate‑polymyxin B ointment, Ambix Laboratories) and ANDAs 074748 and 074808 (captopril tablets and piroxicam capsules, Egis Pharmaceuticals). If approvals are withdrawn, those drug products may not be lawf…

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## Sources
- [2025-23870 on federalregister.gov](https://www.federalregister.gov/documents/2025/12/29/2025-23870/egis-pharmaceuticals-limited-etal-proposal-to-withdraw-approval-of-three-abbreviated-new-drug)
- [2025-23870 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-12-29/pdf/2025-23870.pdf)

## Related
- [Previous: 2025-23869, Agency Information Collection Activities; Proposed Collection; Comment Request;…](https://policyrisk.com/federal-register/2025-23869)
- [Next: 2025-23871, Information Collection Being Reviewed by the Federal Communications Commission…](https://policyrisk.com/federal-register/2025-23871)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-23870 (as of 2026-06-08).