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See today's BioWorld Asia
Home » FDA issues complete response letter to Satsuma for migraine NDA over CMC issues
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FDA issues complete response letter to Satsuma for migraine NDA over CMC issues

Jan. 23, 2024
By Tamra Sami
The U.S. FDA issued a complete response letter to Shin Nippon Biomedical Laboratories Ltd.’s U.S. subsidiary, Satsuma Pharmaceuticals Inc., for its NDA for dihydroergotamine nasal powder (STS-101) for acute treatment of migraine, with or without aura, in adults. Shin Nippon acquired Satsuma for $220 million in April 2023 and gained rights to STS-101.
BioWorld Asia Regulatory Neurology/psychiatric Combination drug-device U.S. FDA

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