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US FDA Filing Mistake For Fintepla Dents Zogenix

 
• By Alexandra Shimmings

Zogenix seems only to have itself to blame for an unexpected refusal to file letter from the US agency for its novel treatment for Dravet syndrome that sent its shares tumbling by 31% on NASDAQ in after-hours trading.

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Zogenix tries to look past Fintepla FDA filing mistakes • Source: Shutterstock

The US FDA has declined to review a new drug application for Zogenix Inc.’s lead investigational treatment, Fintepla (ZX008, low-dose fenfluramine hydrochloride), saying it was not sufficiently complete.

The surprise setback could delay the product in the US by up to 15 months and reduce its peak sales potential, analysts say

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