Topic
What are regulators doing about GLP-1s?
Sourced coverage of GLP-1 approvals, shortages, label changes and enforcement in the US and abroad.
FDA Approval History of Semaglutide: Every Date, ExplainedSemaglutide was first approved as Ozempic on December 5, 2017, followed by Rybelsus (September 20, 2019), Wegovy (June 4, 2021), Wegovy tablets (December 22, 2025) and Wegovy HD (March 19, 2026). Here is each approval, use, and how to verify the dates yourself.Is Compounded Semaglutide FDA Approved? Legal Status and Risks in 2026No. Compounded semaglutide is not FDA approved and never has been. The shortage-based pathway that let pharmacies compound it closed in 2025, courts upheld the FDA in August 2026, and only narrow patient-specific exceptions remain.Is Compounded Tirzepatide Legal in 2026? What FDA Rules SayNo. Mass compounding of tirzepatide became unlawful after FDA resolved the shortage in December 2024 and grace periods closed in 2025. Only narrow 503A exceptions remain, and FDA has received more than 730 adverse event reports for compounded tirzepatide.Is Semaglutide Still in Shortage? FDA Status for 2026No. FDA declared the semaglutide injection shortage resolved on February 21, 2025, and an FDA statement dated April 1, 2026 confirms Ozempic and Wegovy are off the drug shortage list. Local pharmacy stock-outs can still happen.Is Tirzepatide Still in Shortage? FDA Status and TimelineNo. Tirzepatide injection (Mounjaro, Zepbound) came off the FDA drug shortage list on October 2, 2024, and FDA re-confirmed that decision on December 19, 2024. An appeals court upheld the removal on August 27, 2026.Semaglutide Approvals by Country: Where Ozempic and Wegovy Are ApprovedOzempic is approved in the US, EU, UK, Canada, Australia, Japan and China; Wegovy also in India and the UAE. Approved uses and dates differ by market. Canada approved the first G7 generic semaglutide on 28 April 2026 after a patent lapsed over an unpaid CAD 250 fee; US exclusivity runs to 2032.Tirzepatide Approvals by Country: Mounjaro and Zepbound WorldwideTirzepatide is approved for type 2 diabetes and weight management in the US, EU, UK, Canada, Australia, Japan, China and India. The US approved Mounjaro for diabetes on May 13, 2022 and sells the weight-loss version as Zepbound; the UK and Europe use the Mounjaro name for both uses.Tirzepatide FDA Approval History: Mounjaro and Zepbound, Year by YearThe FDA approved tirzepatide as Mounjaro (NDA 215866) on May 13, 2022 for type 2 diabetes and as Zepbound (NDA 217806) on November 8, 2023 for weight management. Later approvals added sleep apnea (December 20, 2024), pediatric diabetes (December 19, 2025), and cardiovascular risk reduction (August 27, 2026).What Does the FDA Say About Ozempic Side Effects and GLP-1 Safety?The FDA's positions live in the drug labels: a boxed warning on thyroid C-cell tumors in rodents, a class-wide anesthesia warning added in 2024, and a suicidal thoughts warning removed on January 13, 2026 after a review of 91 trials. No U.S. warning on NAION vision loss exists as of September 2026.