Posted by Michael Wonder on 09 Mar 2021
Acadia Pharmaceuticals provides regulatory update on supplemental new drug application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis
8 March 2021 - Acadia Pharmaceuticals today announced that the Company received a notification from the U.S. FDA on 3 March 2021, stating that, as part of its ongoing review of the Company’s supplemental new drug application, the FDA has identified deficiencies that preclude discussion of labelling and post-marketing requirements/commitments at this time.
The FDA stated that the notification does not reflect a final decision on the information under review.
