India, Sept. 18 -- Amneal Pharmaceuticals Inc. (AMRX) announced that the U.S. Food and Drug Administration (FDA) has approved its lanreotide injection, 120 mg/0.5 mL, supplied in a sterile, single-dose prefilled syringe. The product is a reference to SOMATULINE Depot and is set for immediate launch in the United States.
The FDA also granted the product Competitive Generic Therapy (CGT) designation, a status intended to encourage the development and market entry of generic medicines with limited competition.
According to IQVIA data, U.S. annual sales of SOMATULINE Depot totaled $983 million for the 12 months ended July 2026.
Lanreotide Injection is indicated for the treatment of acromegaly, advanced gastro-enteropancreatic neuroendocrine ...