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Notice

Egis Pharmaceuticals Limited, et.al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications; Opportunity for a Hearing

Notice.

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Summary:

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.

Key Dates
Citation: 90 FR 60724
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 February 27, 2026. Submit electronic or written comments by February 27, 2026.
Comments close: February 27, 2026
Public Participation

Document Details

Document Number2025-23870
FR Citation90 FR 60724
TypeNotice
PublishedDec 29, 2025
Effective Date-
RIN-
Docket IDDocket No. FDA-2025-N-4684
Pages60724–60726 (3 pages)
Text FetchedNo

Agencies & CFR References

Agency Hierarchy:
Health and Human Services Department→Food and Drug Administration
CFR References:
None

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