Ovation Acquires Lundbeck's Antipsychotic Buronil
This article was originally published in The Pink Sheet Daily
Gaining FDA approval of melperone and two other recently acquired products – the anti-epileptics Sabril (vigabatrin) and Frisium (clobazam) – is a top priority for Ovation. The company has built a portfolio of 11 "under-performing" CNS products in less than two years.
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Ovation plans to submit vigabatrin for the same indication in the coming weeks.
ClinROs, artificial intelligence-based algorithms will be included in approval pathway. FDA is taking a crash course on new techniques for trial assessment thanks to COVID.