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# Reject Apotex Generic Fintepla ANDA: UCB
- URL: https://www.fdaweb.com/reject-apotex-generic-fintepla-anda-ucb/
- Published: 2023-05-17T12:00:00.000Z
- Updated: 2026-09-14T18:32:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154476

UCB is asking FDA to reject an Apotex ANDA for fenfluramine hydrochloride oral solution that cites UCB’s Fintepla as the reference-listed drug. The UCB 5/15 [petition](https://downloads.regulations.gov/FDA-2023-P-1984-0001/attachment%5F1.pdf?ref=fdaweb.com) says that to ensure that generic fenfluramine products are appropriately labeled for the life-threatening pediatric disease Dravet Syndrome (DS), the Apotex ANDA should not be approved unless Apotex’ labeling:

- includes information from the reference-listed drug labeling relating to concomitant administration with stiripentol in treatment of DS; and
- includes dosage modifications and recommendations for patients with hepatic impairment, including those patients on concomitant stiripentol, as added to the Fintepla labeling in 1/2023.