Aquestive Therapeutics Receives FDA Response to Citizen’s Petition
Aquestive Therapeutics, Inc. (AQST)
Last aquestive therapeutics, inc. earnings: 3/11 04:30 pm
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investors.aquestive.com/investor-relations
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Source: GlobeNewswire
WARREN, N.J., Jan. 12, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, today reported that the U.S. Food and Drug Administration (FDA) issued a response letter (Response) dated January 10, 2020 denying Aquestive’s Citizen’s Petition received by the FDA on November 1, 2019, including the supplement to the Citizen’s Petition received by the FDA on December 4, 2019 (Docket No. FDA-2019-P-5121) (Petition). The Petition requested, among other things, that the FDA stay approval of a New Drug Application for Valtoco® (diazepam nasal spray) submitted by Neurelis, Inc. until additional clinical studies were conducted. In the Response, the FDA indicated that it had approved Neurelis’s NDA for Valtoco on January 10, 2020. Valtoco has received orphan drug exclusivity from the FDA’s Center for Drug Evaluation
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