Aquestive Therapeutics Shares Rise 3% After FDA Accepts Libervant NDA
July 19 2021 - 10:29AM
Dow Jones News
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)
Copyright (c) 2021 Dow Jones & Company, Inc.
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