The approval builds on Uzedys 2023 indication for schizophrenia and data from Phase 3 RISE and SHINE trials confirming efficacy and tolerability
While it has shown promise in animal studies, its safety and efficacy in humans have remained uncertain due to a lack of robust clinical trials
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The agency said it intends to take steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies, including Hims & Hers and other compounding pharmacies, as similar alternatives to FDA-approved drugs. This led Hims & Hers to halt sales of certain, lower-cost, non-FDA-approved, copycat versions of drugs like Wegovy and Ozempic
Peptides of this class are typically dissolved, in laboratory protocols, with bacteriostatic water, which contains benzyl alcohol as a preservative and allows longer storage of the dissolved substance
