FDA
FDA OKs first generic GLP-1 injection for weight loss
On August 28, 2025, Teva Pharmaceuticals announced the FDA approval of a generic version of Saxena (liraglutide) indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in:
- Adults and pediatric patients ≥12 years of age with body weight ≥60 kg and obesity
- Adults with overweight in the presence of ≥1 weight-related comorbid condition
Safety
The most common adverse reactions (≥5%) include nausea, diarrhea, constipation, vomiting, injection site reactions, headache, hypoglycemia, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase, upper abdominal pain, pyrexia, and gastroenteritis.
Source:
Teva Announces FDA Approval and Launch of Generic Saxenda® (liraglutide injection) – First Generic GLP-1 Indicated for Weight Loss. [News release]. 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Teva-Announces-FDA-Approval-and-Launch-of-Generic-Saxenda-liraglutide-injection--First-Generic-GLP-1-Indicated-for-Weight-Loss/default.aspx