Aquestive Therapeutics Receives FDA Acceptance of New Drug Application (NDA) for Libervant (diazepam) Buccal Film in Pediatric Patients and Assignment of Prescription Drug User Fee Act (PDUFA) Date
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Aquestive Therapeutics, Inc. (NASDAQ:AQST) has received acceptance from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for pediatric patients aged two to five. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 28, 2024.
September 11, 2023 | 12:08 pm
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Aquestive Therapeutics' new drug application for Libervant has been accepted by the FDA, potentially opening a new market segment for the company.
The FDA's acceptance of Aquestive's NDA for Libervant is a significant step towards the drug's approval. If approved, it could open a new market segment for the company, potentially boosting its revenues and positively impacting its stock price in the short term.
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