A year after CRL, Acadia is going back to bat for Nuplazid at the FDA
A potential blockbuster drug for Acadia Pharmaceuticals is facing a new round of FDA scrutiny in June.
The FDA is holding a public advisory committee meeting on June 17 to discuss a supplemental new drug application for Nuplazid to treat hallucinations and delusions associated with Alzheimer’s disease psychosis.
While Nuplazid is already approved for patients with Parkinson’s disease psychosis, Acadia faced some hurdles when it came to an approval in patients with dementia-related psychosis, including a CRL back in 2021.
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