For body weight greater than 60 kg and obesity. ANDA 214568, held by Teva Pharms. Liraglutide.
As of Nov 15, 2026, ANDA 214568 (Liraglutide), held by Teva Pharms, was first approved by FDA on Aug 27, 2025, with 0 approved supplements and 0 published complete response letters.
Liraglutide injection is 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 aged 12 years and older with body weight greater than 60 kg and obesity. Adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products or with any other glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Liraglutide18MG/3ML (6MG/ML) · solution;subcutaneous | Liraglutide | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
