Posted by Michael Wonder on 04 Dec 2024
Satsuma Pharmaceuticals and SNBL receive FDA acceptance of NDA resubmission of STS101 for the acute treatment of migraine with or without aura
26 November 2024 - Satsuma Pharmaceuticals and its corporate parent Shin Nippon Biomedical Laboratories are pleased to announce that the US FDA has accepted for review a resubmission to original new drug application for the investigational product STS101 (dihydroergotamine nasal powder) for the acute treatment of migraine with or without aura as a complete response to their January 2024 action letter.
The PDUFA date is set as 30 April 2025.
