www.fdanews.com/articles/195048-aquestive-therapeutics-gets-fda-approval-for-exservan-oral-film-for-als
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Aquestive Therapeutics Gets FDA Approval for Exservan Oral Film for ALS
December 8, 2019
The FDA approved Aquestive Therapeutics’ Exservan (riluzole) oral film treat amyotrophic lateral sclerosis (ALS).
Exservan is a novel formulation of riluzole, a glutamate blocker currently used as an adjunctive therapy to treat ALS. It is administered in one 50 mg dose twice daily.
The oral film received orphan drug designation in January 2018.
Aquestive has licensed the product to Italian drugmaker Zambon for marketing in the EU for treatment of ALS.