Satsuma Pharmaceuticals and SNBL resubmits the new drug application for STS101 (dihydroergotamine nasal powder) for the acute treatment of migraine with or without aura

Satsuma Pharmaceuticals

30 October 2024 - Satsuma Pharmaceuticals and its corporate parent, Shin Nippon today announced the resubmission of the new drug application for the investigational product STS101 (dihydroergotamine nasal powder) for the acute treatment of migraine with or without aura.

The US FDA issued a complete response letter in January 2024 for the original new drug application submitted in March 2023. 

Read Satsuma Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Dossier