Brief: Aquestive Therapeutics Announces Positive FDA Feedback and Reaffirms NDA Submission Guidance for Anaphylm Sublingual Film
02/12/2024 13:26
Dec 2 (Reuters) - Aquestive Therapeutics Inc AQST.O :
* AQUESTIVE THERAPEUTICS ANNOUNCES POSITIVE FDA FEEDBACK AND
REAFFIRMS NDA SUBMISSION GUIDANCE FOR ANAPHYLM™ (EPINEPHRINE)
SUBLINGUAL FILM
* AQUESTIVE THERAPEUTICS INC -CONFIRMS NO ADDITIONAL ADULT
CLINICAL TRIALS ARE NECESSARY PRIOR TO NDA SUBMISSION
* AQUESTIVE THERAPEUTICS INC -REAFFIRMS NEW DRUG APPLICATION
(NDA)
Q1 2025 SUBMISSION GUIDANCE
Source text: ID:nGNX6xwWj2
Further company coverage: AQST.O
((Reuters.Briefs@thomsonreuters.com;))
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