The U.S. Food and Drug Administration (FDA) has rejected Acadia Pharmaceuticals’ request that Nuplazid (pimavanserin) be the first approved treatment of hallucinations and delusions associated with dementia-related psychosis. The decision comes less than nine months since the agency agreed to review the company’s supplemental new drug application, and a month after it announced “deficiencies” that had to be resolved before further discussions on “labeling and post-marketing requirements/commitments” could take place. While the FDA’s complete response letter (CRL) did not…
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