By Chris Wack

 

Aquestive Therapeutics Inc. shares were up 3% to $3.42 after the company said the U.S. Food and Drug Administration has accepted for filing the resubmission of the New Drug Application for Libervant diazepam Buccal Film for the management of seizure clusters.

The pharmaceutical company said the FDA has assigned a Prescription Drug User Fee Act target goal date of Dec. 23, 2021.

Aquestive said the commercial launch of Libervant, if approved for U.S. market access, would be in the first half of 2022.

Aquestive received a Complete Response Letter from the FDA in September 2020, completed a Type A meeting with the FDA in November 2020 and received further guidance from the FDA in February 2021. The company said it believes that no additional clinical studies will be required for FDA approval of Libervant for U.S. market access.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

July 19, 2021 10:21 ET (14:21 GMT)

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