The medication is indicated for patients suffering from acromegaly, a rare hormonal disorder, as well as those with advanced gastro-enteropancreatic neuroendocrine tumors and carcinoid syndrome. By controlling hormone levels, the drug aims to improve progression-free survival rates while reducing the necessity for additional rescue therapies in patients whose tumors release excessive hormones.

Amneal reported that the branded version of the treatment, owned by the French pharmaceutical firm Ipsen Pharma, saw U.S. sales reach $983 million during the 12-month period ending in July. This regulatory clearance allows Amneal to capture a significant share of the specialized oncology and endocrinology market previously dominated by the trademarked Somatuline Depot.