Satsuma Pharmaceuticals, Inc., and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. announced that the FDA accepted for review a resubmission to original new drug application (NDA) 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 Prescription Drug User Fee Act (PDUFA) date is set as April 30, 2025.
Almost 40 million people in the United States suffer from migraine, especially among working women in their 20s to 40s. The U.S. market for acute migraine medications is estimated to be over USD 1.0 Billion.
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