Keeping Track: Allergan Antipsychotic Vraylar Approved; First-Line Imbruvica Claim Submitted

The latest drug development news and highlights from our FDA Performance Tracker.

Allergan PLC's antipsychotic Vraylar became the 25th novel drug approved by FDA's Center for Drug Evaluation and Research in 2015. New submissions were plentiful, including a first-line claim for AbbVie Inc. and Johnson & Johnson's Imbruvica, and another breakthrough designation was awarded to Bristol-Myers Squibb Co.'s checkpoint inhibitor immunotherapy Opdivo.

The atypical antipsychotic Vraylar (cariprazine) was approved on Sept. 17 to treat schizophrenia and acute manic or mixed episodes of...

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