Topic
What has the FDA approved, and when?
Approvals, shortages, label changes and enforcement, in the US and abroad.
Is Compounded Semaglutide FDA Approved? The 2026 Rules ExplainedCompounded semaglutide is not FDA approved and never has been, and since the 2025 shortage delisting most routine compounding of Ozempic and Wegovy copies is no longer lawful.Is Compounded Tirzepatide Legal in 2026? What the FDA Actually SaysLarge-scale compounding of tirzepatide copies lost its legal basis on February 18, 2025 for pharmacies and March 19, 2025 for outsourcing facilities. A narrow path remains for small-volume, patient-specific compounding, and the FDA has spelled out where the line sits.Is Semaglutide Still in Shortage? What the FDA List Says in 2026The FDA declared the semaglutide injection shortage resolved on February 21, 2025, and it has not returned since, which is why compounded copies of Ozempic and Wegovy are no longer generally legal.Is Tirzepatide Still in Shortage? The Full Mounjaro and Zepbound TimelineTirzepatide came off the FDA drug shortage list on October 2, 2024, was put back under review after a lawsuit, and was declared resolved again on December 19, 2024. It has stayed off the list ever since, and courts have upheld that decision twice.Semaglutide Approvals by Country: Where Ozempic and Wegovy Are ApprovedA country-by-country guide to semaglutide approvals, from the US and EU to Canada's first-in-the-G7 generics, plus where the Wegovy pill is available and where the labels disagree.The Complete FDA Approval History of Semaglutide (2017-2026)Every FDA approval, new indication and major label change for semaglutide from the first Ozempic approval in December 2017 through the Wegovy pill, Wegovy HD 7.2 mg and the Ozempic tablets rebrand in 2026.The Complete FDA Approval History of Tirzepatide (Mounjaro and Zepbound)Tirzepatide has two US brand names, two application numbers and six separate approved uses. Here is every FDA decision from the May 13, 2022 Mounjaro approval through the August 2026 cardiovascular indication, with the supplement numbers and trial names behind each one.Tirzepatide Approvals Around the World: Mounjaro and Zepbound by CountryTirzepatide is approved in the US, EU, UK, Canada, Japan, China, Australia, India and beyond, but the brand names and the approved uses differ by country. In the UK and EU, Mounjaro is also the weight-loss brand, which trips up a lot of American readers.What the FDA Says About GLP-1 Safety: Every Warning on the LabelA plain-English tour of the FDA's official safety positions on semaglutide and the GLP-1 class, including the boxed warning, the anesthesia warning, the warning the FDA removed in 2026, and the one Europe added that the US has not.