While one study did show statistical significance, the FDA said in a Complete Response Letter that it was insufficient on its own [to provide] substantial evidence of effectiveness. The FDA also noted that the NDA submission lacked data on concomitant antipsychotic administration, did not include data that established that the change in negative symptoms was clinically meaningful and that the submitted safety database had an inadequate number of subjects exposed to roluperidone at the proposed dose of 64 mg for at least 12 months
If so, both the generic version and Wegovy would have the same active ingredient: semaglutide
ProHealth discloses full Supplement Facts (no proprietary blends), publishes triple third-party lab Certificates of Analysis, and backs the formula with a 100-day return window - all verifiable at prohealth.com
Clinical data are scarce
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