Back to the article

HealthRX.com · Printable medication review sheet

Wegovy approved-use and dose check

Match your prescription to one of the uses FDA has approved for Wegovy, note your form and dose, and see which approvals are newer than the label you were given. Questions for your prescriber are at the end.

Companion to “Wegovy FDA Approval History: Timeline, Label Changes, and Safety Updates” · healthrx.com/regulatory-wegovy/fda-approval-history · Facts checked 2026-10-19

Your prescription

Use it was prescribed foradult or adolescent weight management, heart and stroke risk, MASH
Formweekly injection or daily tablet
Current dose and the dose you are aiming for
Revision date on your Medication Guide

Approved uses and forms, by FDA approval date

  • June 4, 2021: chronic weight management in adults.[1]
  • December 23, 2022: chronic weight management in adolescents 12 and older with a BMI at the 95th percentile or greater.[2]
  • March 8, 2024: reducing major adverse cardiovascular events in adults with established cardiovascular disease and obesity or overweight.[3]
  • August 15, 2025: noncirrhotic MASH with moderate to advanced liver fibrosis (F2 to F3) in adults, under accelerated approval.[4]
  • December 22, 2025: Wegovy tablets approved as a new dosage form.[5]
  • March 19, 2026: a 7.2 mg weekly injection dose added.[6]

Two points the newest letters make

  • The MASH approval is accelerated: FDA may withdraw it if the required trials fail to verify clinical benefit. The final report of the required trial is due December 2029.[4]
  • Heart-failure results from SELECT were added in November 2025 with a footnote that an effect on heart failure has not been established.[7]

For your prescriber

  1. Which approved use is my prescription written for, and is it the one my insurer is reviewing?
  2. Is my maintenance dose one that is approved for my age group?
  3. If I am treated for MASH, how will my liver fibrosis be followed over time?
  4. Would the tablet suit me better than the injection, and how would a change be made?
  5. Has anything been added to the label since the version I was given?
Sources for the facts on this sheet
  1. U.S. Food and Drug Administration. NDA 215256 approval letter for Wegovy (semaglutide) injection. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215256Orig1s000ltr.pdf
  2. U.S. Food and Drug Administration. NDA 215256/S-005 supplement approval letter for Wegovy (semaglutide) injection. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215256Orig1s005ltr.pdf
  3. U.S. Food and Drug Administration. NDA 215256/S-011 supplement approval letter for Wegovy (semaglutide) injection. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215256Orig1s011ltr.pdf
  4. U.S. Food and Drug Administration. NDA 215256/S-024 supplement approval letter for Wegovy (semaglutide) (MASH, accelerated approval). Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215256Orig1s024ltr.pdf
  5. U.S. Food and Drug Administration. Drugs@FDA: Wegovy (semaglutide) tablets NDA 218316, approval history, letters, labels and reviews. Accessed 2026-10-19. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218316
  6. U.S. Food and Drug Administration. NDA 215256/S-029 and NDA 218316/S-005 supplement approval letter for Wegovy (semaglutide) injection and tablets. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215256Orig1s029;218316Orig1s005ltr.pdf
  7. U.S. Food and Drug Administration. NDA 215256/S-023 supplement approval letter for Wegovy (semaglutide) injection. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215256Orig1s023ltr.pdf

This sheet records information for a conversation with your prescriber or pharmacist. It does not replace their instructions or the medication's prescribing information.