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DISCOVERY, INC.'s DEPRENYL NDA LACKS "ADEQUATE EVIDENCE OF SAFETY

Executive Summary

DISCOVERY, INC.'s DEPRENYL NDA LACKS "ADEQUATE EVIDENCE OF SAFETY, effectiveness, proper methods, facilities and controls, environmental assessment, proper labeling, bioavailability data, and compliance with [current Good Manufacturing Practices] regulations," FDA declares in a notice of opportunity for a hearing published May 19 in the Federal Register. The agency intends to refuse approval of Discovery Experimental & Development, Inc.'s NDA (20-242) for deprenyl citrate for treatment of Alzheimer's disease, the notice states. Discovery has until late June to request a hearing.
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