Aquestive Therapeutics announced that the U.S. FDA has accepted the company’s New Drug Application for the investigational product riluzole oral film, which the company intends to market under the brand name Exservan. ROF is a novel formulation of riluzole, which is used as an adjunctive therapy in the treatment of amyotrophic lateral sclerosis. The PDUFA goal date is November 30. The company is exploring commercial opportunities for ROF in the U.S. and abroad.
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