FDA Status and Approval Updates
Approval status for every product in our directory, with the date each record was last verified against a primary FDA source.
How we handle FDA news
We do not publish an approval, labeling change, or safety communication until a person has confirmed it against a primary FDA source — Drugs@FDA, the product’s prescribing information on DailyMed, or an official FDA communication. We do not repost drug news from press coverage or social media. When a status changes, the drug record changes and the verification date on this page moves with it.
Current FDA status by product
| Product | Status (for weight management) | Approval history |
|---|---|---|
| Semaglutide | FDA ApprovedApproved for chronic weight management | First semaglutide approval: December 2017 (Ozempic). Weight-management approval: June 2021 (Wegovy). |
| Tirzepatide | FDA ApprovedApproved for chronic weight management | First tirzepatide approval: May 2022 (Mounjaro). Weight-management approval: November 2023 (Zepbound). |
| Liraglutide | FDA ApprovedApproved for chronic weight management | First liraglutide approval: January 2010 (Victoza). Weight-management approval: December 2014 (Saxenda). |
| Orlistat | FDA ApprovedApproved for chronic weight management | Xenical: April 1999 (prescription). Alli: February 2007 (over the counter). |
| Phentermine | FDA ApprovedApproved for chronic weight management | 1959 |
| Phentermine-topiramate (extended release) | FDA ApprovedApproved for chronic weight management | July 2012 |
| Naltrexone-bupropion (extended release) | FDA ApprovedApproved for chronic weight management | September 2014 |
| Wegovy | FDA ApprovedApproved for chronic weight management | June 2021 (adults); December 2022 (adolescents 12+); March 2024 (cardiovascular risk reduction) |
| Ozempic | FDA Approved for a Different IndicationNot approved for weight management | December 2017 |
| Zepbound | FDA ApprovedApproved for chronic weight management | November 2023 (weight management); December 2024 (obstructive sleep apnea) |
| Mounjaro | FDA Approved for a Different IndicationNot approved for weight management | May 2022 |
| Saxenda | FDA ApprovedApproved for chronic weight management | December 2014 (adults); December 2020 (adolescents 12+) |
| Retatrutide | InvestigationalNot FDA approved | No FDA approval |
| Orforglipron | InvestigationalNot FDA approved | No FDA approval |
Last checked: August 12, 2026 — all records verified against Drugs@FDA and DailyMed labeling
Approval history
First FDA approval per product, oldest to newest. Each product page links to its official prescribing information, where the current approved labeling always governs.
1959
Xenical: April 1999 (prescription). Alli: February 2007 (over the counter).
July 2012
- 2014Naltrexone-bupropion (extended release)Opioid antagonist + aminoketone antidepressant (combination)
September 2014
December 2014 (adults); December 2020 (adolescents 12+)
December 2017
June 2021 (adults); December 2022 (adolescents 12+); March 2024 (cardiovascular risk reduction)
May 2022
November 2023 (weight management); December 2024 (obstructive sleep apnea)
Investigational compounds
Compounds in clinical development are tracked in our directory with an Investigational — not FDA approved status. Regulatory status can change; a compound listed as investigational here may have a different status by the time you read this, so check FDA sources directly. We never describe an investigational compound as approved, and we never link to a seller of one.
Sources
- Drugs@FDA: FDA-approved drug products — FDA. Link last verified August 12, 2026.
- DailyMed prescribing information database (NIH) — DailyMed/NIH. Link last verified August 12, 2026.
- FDA drug safety communications — FDA. Link last verified August 12, 2026.
Not medical advice. WeightLossDrugsGuide is an independent educational publisher. We are not a pharmacy, a medical provider, or a telehealth clinic, and we do not provide personalized medical recommendations or dosing guidance. Information here summarizes official FDA labeling and other primary sources and may not reflect the most recent changes. Always talk with a licensed clinician about your own situation, and read the full prescribing information for any medication.