lanreotide injection, 120 mg/0.5 mL

September 18, 2026: Amneal Pharmaceuticals (NASDAQ: AMRX) announced FDA approval of lanreotide injection, 120 mg/0.5 mL, in a sterile single-dose prefilled syringe, referencing SOMATULINE Depot, with immediate U.S. commercial launch. The product received FDA Competitive Generic Therapy designation.

Lanreotide is indicated for treatment of acromegaly, advanced gastro-enteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome. The company states it helps control hormone levels in acromegaly, improves progression-free survival in eligible GEP-NET patients, and reduces the need for rescue therapy in carcinoid syndrome.

Amneal said the launch is supported by in-house manufacturing capacity. The press release also notes U.S. annual sales for SOMATULINE Depot were $983 million for the 12 months ended July 2026, according to IQVIA.