Amneal Wins FDA Approval and Launches Generic Lanreotide 120 mg Injection with Competitive Generic Therapy Designation; Reference Product Somatuline Depot Had $983M in U.S. Sales
Amneal Pharmaceuticals announced on Friday, September 18, 2026 that the FDA approved its lanreotide injection, 120 mg/0.5 mL, in a sterile single-dose prefilled syringe referencing Somatuline Depot, and that it would launch immediately. The product is indicated for acromegaly, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome. The FDA gave it Competitive Generic Therapy designation. Somatuline Depot had U.S. sales of $983 million for the 12 months ended July 2026, according to IQVIA data cited by Amneal.