The approval was based on safety and efficacy data from clinical trials evaluating diazepam rectal gel, as well as adult bioavailability studies comparing Libervant with diazepam rectal gel, adult and pediatric pharmacokinetic data, and an open-label safety study of Libervant.
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The approval was based on safety and efficacy data from clinical trials evaluating diazepam rectal gel, as well as adult bioavailability studies comparing Libervant with diazepam rectal gel, adult and pediatric pharmacokinetic data, and an open-label safety study of Libervant.
Aquestive Therapeutics Receives U.S. FDA Approval And Market Access For Libervant™ (Diazepam) Buccal Film In Pediatric Patients Ages 2 To 5 And Provid... menafn.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from menafn.com Daily Mail and Mail on Sunday newspapers.