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Federal law (via DEA waivers extended through December 31, 2025) allows prescribing controlled substances via telehealth without an initial in-person exam
PT-141 has undergone full Phase 3 clinical trials with over 1,200 subjects and received FDA approval as bremelanotide (Vyleesi) for female hypoactive sexual desire disorder in 2019, which means it has passed formal safety and efficacy review
Rafiullah, M
Filippatos TD, Elisaf MS
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