FDA Approves and Launches Generic Lanreotide Injection Referencing Somatuline Depot

Clinical Summary: 

• Regulatory Update: The FDA approved Amneal’s lanreotide injection, supplied as a 120 mg/0.5 mL sterile, single-dose prefilled syringe, referencing Somatuline Depot. The product also received Competitive Generic Therapy designation and is being launched immediately.
• Indications: Lanreotide injection is indicated for acromegaly, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome.
• Clinical Relevance: The approval introduces an additional lanreotide product for US patients, providing another long-acting injectable option for controlling hormone levels in acromegaly, improving progression-free survival in eligible patients with advanced GEP-NETs, and reducing rescue therapy requirements in carcinoid syndrome.

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ lanreotide injection, 120 mg/0.5 mL, in a sterile, single-dose prefilled syringe for the treatment of acromegaly, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome.

The product references lanreotide (Somatuline Depot; Ipsen Pharma) and received Competitive Generic Therapy designation from the FDA. According to Amneal, the product is being launched immediately in the United States.

Lanreotide is a long-acting somatostatin analog with applications across several endocrine and neuroendocrine conditions. In patients with acromegaly, treatment is used to control elevated hormone levels.

For patients with advanced GEP-NETs, lanreotide is indicated to improve progression-free survival in eligible patients. GEP-NETs are neuroendocrine tumors originating within the gastrointestinal tract or pancreas and represent an established setting for long-acting somatostatin analog therapy.

Lanreotide is also indicated for carcinoid syndrome, where treatment can reduce the need for rescue therapy associated with disease-related symptoms.

The newly approved formulation contains 120 mg/0.5 mL of lanreotide in a sterile, single-dose prefilled syringe.

The FDA's Competitive Generic Therapy designation applies to generic drugs for which inadequate generic competition exists and is intended to facilitate development and review of these products.

The approval expands the availability of lanreotide in the United States and provides an additional long-acting injectable option across its approved indications.

Source: 

Amneal. Amneal announces FDA approval and launch of lanreotide injection. Accessed on September 23, 2026. https://investors.amneal.com/news/press-releases/press-release-details/2026/Amneal-Announces-FDA-Approval-and-Launch-of-Lanreotide-Injection/default.aspx