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Limited Scope of FDA Approval The most significant limitation is the narrow approved indication: FDA approval restricted exclusively to acquired, generalized hypoactive sexual desire disorder in premenopausal women No approved indication for men despite Phase 2 evidence of erectile dysfunction improvement No approval for postmenopausal women No approval for other forms of sexual dysfunction beyond HSDD All use outside this single indication represents off-label prescribing based on limited clinical trial data and physician clinical experience

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PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy (June 2025)

Testing Methodology Every batch undergoes a multi-stage analytical pipeline before release