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Regulatory Timeline (According to FDA Announcements): October 2, 2024: FDA indicated tirzepatide shortage resolved (later superseded) December 19, 2024: FDA issued a declaratory order reaffirming shortage resolution February 18, 2025: 503A enforcement discretion ended March 19, 2025: 503B enforcement discretion ended Industry Context: Some reporting has described ongoing disputes about how certain compounded tirzepatide formulations are marketed following shortage-related enforcement discretion changes
Semaglutide was superior to placebo in terms of the trials primary endpoint, mean percentage change in BMI at week 68 (16.1% decrease vs 0.6% increase)
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