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STS101 FDA Approval Status

Last updated by Judith Stewart, BPharm on Dec 4, 2024.

FDA Approved: No
Brand name: STS101
Generic name: dihydroergotamine mesylate
Company: Satsuma Pharmaceuticals, Inc.
Treatment for: Migraine

STS101 (dihydroergotamine mesylate) is a proprietary nasal powder formulation of the ergotamine derivative dihydroergotamine mesylate in development for the acute treatment of migraine.

Development timeline for STS101

DateArticle
Nov 26, 2024Satsuma Pharmaceuticals and SNBL Receive FDA Acceptance of NDA Resubmission of STS101 for the Acute Treatment of Migraine With or Without Aura
Oct 30, 2024Satsuma Pharmaceuticals and SNBL Resubmits the New Drug Application for STS101 (Dihydroergotamine Nasal Powder) for the Acute Treatment of Migraine With or Without Aura
Jan 18, 2024FDA Issues Complete Response Letter for Satsuma’s STS101
May 18, 2023Satsuma Pharmaceuticals Announces FDA Acceptance of 505(b)(2) NDA for STS101, a Novel and Investigational Dihydroergotamine (DHE) Nasal Powder Product for the Acute Treatment of Migraine
Jul 28, 2021Satsuma Pharmaceuticals Announces First Subject Randomized in SUMMIT™, a Phase 3 Efficacy Trial of STS101 for the Acute Treatment of Migraine
Sep 10, 2020Satsuma Pharmaceuticals Announces Topline Results from EMERGE Phase 3 Trial of STS101 for the Acute Treatment of Migraine

Further information

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