FDA Calendar

Company Name ACADIA Pharmaceuticals Inc
Drug Name NUPLAZID (Resubmitted sNDA)
Event Name FDA decision on NUPLAZID for the expanded use in treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis
Event Date 08/04/2022
Outcome Date 08/05/2022
Outcome FDA declines to approve NUPLAZID for the expanded use in treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis on Aug.5, 2022
Drug Status
Rival Drugs There are no FDA-approved treatments for Alzheimer’s disease psychosis. However, atypical antipsychotic agents like Aripiprazole are used off-label for treating Alzheimer’s disease psychosis.
Market Potential For 2022, the company expects NUPLAZID net sales in Parkinson’s disease psychosis to range between $510 million and $560 million.
Other Approvals NUPLAZID was approved by the FDA for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis in April 2016.
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