Federal Register #2026-11062

FDA Withdrawal of Approval for 16 Abbreviated New Drug Applications

This notice announces the FDA's withdrawal of approval for 16 abbreviated new drug applications (ANDAs) from multiple pharmaceutical manufacturers: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Elite Laboratories, Inc. - AbbVie Inc. - Par Health USA LLC (for PH Health Limited) - Sunstar Americas, Inc. - eVenus Pharmaceutical Lab Inc. (for Jiangsu Hengrui Pharmaceuticals Co., Ltd.) - Navinta LLC - PTS Consulting, LLC (for TP ANDA HOLDINGS, LLC) - Makro Technologies Inc. (for Aizant Drug Research Solutions Private Limited) - Eagle Pharmaceuticals, Inc. - CMC GMP LLC (for Pharmadax Inc.) - Products/Services: - 16 ANDAs covering various strengths and dosage forms (specific part numbers and quantities not provided) - Notable Requirements: - Withdrawal initiated at the request of the applicants - Applies to all strengths and dosage forms for the listed applications - Action is without prejudice to refiling in the future - No procurement or contract award is involved; this is a regulatory action - Place of Performance/Contact: - Food and Drug Administration, Silver Spring, MD

Description

The Food and Drug Administration (FDA) is withdrawing approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the FDA that the drug products are no longer marketed and requested withdrawal of approval. This action is a formal notice from the FDA and approval is withdrawn as of July 6, 2026. The withdrawal is without prejudice to refiling and includes all amendments and supplements to the applications.

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