FDA Revokes Drug Nods Over Egis' Missing Reports
Published Date: 12/29/2025
Notice
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 This could affect the availability of these drugs and might impact the companies financially if approvals are withdrawn.
Analyzed Economic Effects
2 provisions identified: 0 benefits, 2 costs, 0 mixed.
ANDA Holders: Hearing Deadline or Waiver
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 314.81 and 314.98; if you do not timely request a hearing you waive the right to contest withdrawal.
Possible Removal of Three Generic Drugs
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 If approvals are withdrawn, those drug products may not be lawfully introduced or delivered for introduction into interstate commerce.
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