The U.S. Food and Drug Administration (FDA) found “deficiencies” that preclude discussing further steps in the approval process for Nuplazid (pimavanserin) as a possible treatment of dementia-related psychosis, according to a press release from Acadia Pharmaceuticals, Nuplazid’s maker. Discussions on “labeling and post-marketing requirements/commitments” cannot take place before certain issues related to the therapy’s supplemental new drug application (sNDA) are resolved, the FDA notification stated. The FDA’s notice to Acadia is not a final decision on the application,…
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