U.S. FDA accepts Biohaven's supplemental new drug application of Nurtec ODT for the preventive treatment of migraine

Biohaven Pharmaceutical

14 October 2020 - Acceptance marks critical milestone in Biohaven's efforts to develop Nurtec ODT as a unique dual therapy for both the preventive and acute treatment of migraine.

Biohaven Pharmaceutical today announced that the U.S. FDA has filed and accepted for review its recently submitted supplemental new drug application for Nurtec ODT (rimegepant) for the preventive treatment of migraine. 

The Prescription Drug User Fee Act goal date for completion of the FDA review of the preventive supplemental new drug application is set for 2Q, 2021.

Read Biohaven Pharmaceutical press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier