Acacia Pharma announces brief extension of FDA review period for NDA for Byfavo, an ultra-short acting and reversible anesthetic for procedural sedation

Acacia Pharma

12 March 2020 - Acacia Pharma announces that the US FDA has extended the review period for the new drug application for Byfavo (remimazolam) by up to 90 days in order to complete its review of additional data submitted in January and February 2020.

FDA has set a new Prescription Drug User Fee Act goal of reviewing and acting on the NDA of no later than 5 July 2020 (previous PDUFA target date was 5 April 2020).

Read Acacia Pharma press release

Michael Wonder

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Michael Wonder

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Medicine , Timelines , Dossier