Safety update
Compounded semaglutide
FDA continued enforcement actions against compounding pharmacies producing semaglutide outside the Section 503A/503B framework after the shortage resolved.
Source: fda.gov →Loading content…
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FDA regulatory history
Every FDA action that shaped today's GLP-1 landscape — original approvals, indication expansions, safety updates, shortage status changes, and discontinuations. Sourced from fda.gov primary documents.
38 regulatory events across 15 medications · 2005 → 2026
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FDA continued enforcement actions against compounding pharmacies producing semaglutide outside the Section 503A/503B framework after the shortage resolved.
Source: fda.gov →FDA reaffirmed enforcement against unauthorized compounded tirzepatide after court ruling — outsourcing facilities ordered to halt production.
Source: fda.gov →FDA approved Ozempic for reducing risk of worsening kidney disease, kidney failure, and CV death in adults with T2D and chronic kidney disease (FLOW trial).
Source: fda.gov →FDA approved Zepbound for treatment of moderate-to-severe obstructive sleep apnea in adults with obesity (SURMOUNT-OSA trial). First medication approved for OSA.
Source: fda.gov →FDA resolved semaglutide shortage — Wegovy and Ozempic removed from active shortage list. Initiated compounder wind-down timeline.
Source: 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.
Source: fda.gov →FDA removed tirzepatide from shortage list — 503A compounders required to stop production within 60 days, 503B within 90 days.
Source: 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.
Source: fda.gov →FDA updated Mounjaro and Zepbound labels to strengthen pulmonary aspiration warnings for patients undergoing anesthesia.
Source: 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.
Source: 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.
Source: fda.gov →Tirzepatide approved for chronic weight management at doses to 15 mg/week. SURMOUNT-1 trial showed ~22% body-weight reduction at 72 weeks.
Source: fda.gov →FDA updated Ozempic, Wegovy, and Saxenda labels to include ileus (intestinal blockage) as adverse reaction following postmarket reports.
Source: fda.gov →FDA issued public alert about adverse events from compounded semaglutide — flagged use of semaglutide salt forms (sodium, acetate) not present in FDA-approved products.
Source: fda.gov →Sanofi discontinued Adlyxin in the US market for commercial reasons.
Source: fda.gov →FDA expanded Wegovy approval to pediatric patients aged 12 years and older with obesity (STEP TEENS trial).
Source: fda.gov →FDA added Mounjaro to the Drug Shortage List due to demand exceeding supply.
Source: fda.gov →FDA added Ozempic 0.25, 0.5, 1, and 2 mg presentations to the Drug Shortage List due to increased demand for off-label weight-loss use.
Source: fda.gov →First dual GIP/GLP-1 receptor agonist approved — once-weekly tirzepatide for type 2 diabetes. SURPASS trial program showed superior A1C reduction vs semaglutide.
Source: fda.gov →FDA added Wegovy to the Drug Shortage List due to manufacturing constraints — shortage persisted intermittently via 2024.
Source: fda.gov →Semaglutide 2.4 mg approved for chronic weight management in adults with BMI ≥30 (or ≥27 with comorbidity). STEP-1 trial showed ~15% body-weight reduction.
Source: fda.gov →FDA expanded Saxenda approval to pediatric patients aged 12 years and older with obesity — first GLP-1 for adolescent weight management.
Source: fda.gov →FDA approved Trulicity for reducing risk of major adverse cardiovascular events in adults with T2D with or without established CV disease (REWIND trial).
Source: fda.gov →FDA approved Ozempic for reducing risk of major adverse cardiovascular events in adults with T2D and established CV disease (SUSTAIN-6 trial).
Source: fda.gov →First oral GLP-1 receptor agonist approved — once-daily tablet semaglutide for type 2 diabetes. Required strict 30-min fasting protocol for absorption.
Source: fda.gov →FDA approved Victoza for treatment of type 2 diabetes in pediatric patients aged 10 years and older — first non-insulin T2D treatment approved for pediatric use since 2000.
Source: fda.gov →GlaxoSmithKline voluntarily discontinued Tanzeum for commercial reasons. No safety or efficacy issues cited.
Source: fda.gov →Once-weekly semaglutide injection approved for type 2 diabetes. SUSTAIN trial program showed superior A1C and weight reduction vs comparators.
Source: fda.gov →BCise autoinjector formulation approved — improved once-weekly exenatide delivery with single-use autoinjector.
Source: fda.gov →FDA approved Victoza for reducing risk of major adverse cardiovascular events (MACE) in adults with T2D and established CV disease (LEADER trial).
Source: fda.gov →Once-daily lixisenatide approved for type 2 diabetes.
Source: fda.gov →Liraglutide approved at 3 mg dose for chronic weight management in adults with BMI ≥30 (or ≥27 with comorbidity). First daily GLP-1 for obesity indication.
Source: fda.gov →Once-weekly dulaglutide approved for type 2 diabetes. Single-use autoinjector pen with pre-attached needle.
Source: fda.gov →Once-weekly albiglutide approved for type 2 diabetes.
Source: fda.gov →Extended-release once-weekly exenatide approved for type 2 diabetes — first weekly GLP-1 injection.
Source: fda.gov →Once-daily liraglutide approved for type 2 diabetes. First GLP-1 with a boxed warning for risk of thyroid C-cell tumors (animal data).
Source: fda.gov →FDA issued safety information regarding acute pancreatitis reports in Byetta patients — labeling updated.
Source: fda.gov →First GLP-1 receptor agonist approved in the US — twice-daily exenatide injection for type 2 diabetes as adjunct to metformin or sulfonylurea.
Source: fda.gov →