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Allergan Seeks Quick Vraylar Turnaround After US FDA Refuses To File

 
• By Sten Stovall

Supplemental application for negative symptoms associated with schizophrenia has robust data, Datamonitor Healthcare analyst suggests, but was incomplete.

Madness

Allergan PLC is urgently seeking guidance from the US FDA to learn what prevented its supplemental new drug application (sNDA) for Vraylar (cariprazine) to treat negative symptoms associated with schizophrenia from being filed for review.

After conveying optimism about the future of its schizophrenia drug Vraylar, which has a different mechanism of action compared to...

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