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FDA approvals
8 regulatory events affecting GLP-1 medications in 2024.
FDA approved Zepbound for treatment of moderate-to-severe obstructive sleep apnea in adults with obesity (SURMOUNT-OSA trial). First medication approved for OSA.
Read on fda.gov →FDA resolved semaglutide shortage — Wegovy and Ozempic removed from active shortage list. Initiated compounder wind-down timeline.
Read on fda.gov →FDA resolved tirzepatide shortage — Mounjaro and Zepbound removed from active shortage list. 503A compounders given 60-day wind-down, 503B given 90-day.
Read on fda.gov →FDA removed tirzepatide from shortage list — 503A compounders required to stop production within 60 days, 503B within 90 days.
Read on fda.gov →FDA updated GLP-1 labels to strengthen warnings about pulmonary aspiration risk during anesthesia for surgery — recommended stopping medication before procedures requiring sedation.
Read on fda.gov →FDA updated Mounjaro and Zepbound labels to strengthen pulmonary aspiration warnings for patients undergoing anesthesia.
Read on fda.gov →FDA proposed adding semaglutide and tirzepatide to the Demonstrably Difficult to Compound (DDC) list, which would restrict 503A pharmacy compounding even during shortage.
Read on fda.gov →FDA approved Wegovy for reducing risk of major adverse cardiovascular events in adults with established CV disease and either obesity or overweight (SELECT trial). First obesity drug with CV benefit indication.
Read on fda.gov →