FDA approves Amneal lanreotide injection referencing Somatuline Depot
The FDA has approved and Amneal has launched a 120 mg/0.5 mL lanreotide injection referencing Somatuline Depot, expanding competition in the US complex-injectables market.
The product received Competitive Generic Therapy designation and is used in indications including acromegaly and gastroenteropancreatic neuroendocrine tumours.
The immediate commercial launch gives clinicians and patients another lanreotide treatment option and supports Amneal's strategy of expanding its portfolio of complex generic and specialty injectable products.
Field | Content |
Alert Type | Approval |
Drug Name | Lanreotide injection |
Company | Amneal Pharmaceuticals |
Regulatory Authority | U.S. Food and Drug Administration |
Approval Type | Generic drug approval and commercial launch |
Reference Product | Somatuline Depot |
Strength | 120 mg/0.5 mL |
Regulatory Designation | Competitive Generic Therapy |
Indication | Approved lanreotide indications including acromegaly and gastroenteropancreatic neuroendocrine tumours |
Therapy Area(s) | Endocrinology; oncology; neuroendocrine tumours |
Technology or Modality | Complex injectable generic |
Geography | United States |
What Happened | The FDA approved Amneal's lanreotide 120 mg/0.5 mL injection referencing Somatuline Depot, and the company launched the product immediately. |
Why It Matters | The approval introduces additional competition in a complex injectable medicine used across endocrine and neuroendocrine tumour care. |
Supporting Context | Lanreotide is a long-acting somatostatin analogue used in acromegaly and for management of certain gastroenteropancreatic neuroendocrine tumours. |
Potential Impact | Additional competition may improve treatment availability and create greater pricing choice for healthcare providers and patients. |
Key Takeaway | Amneal has secured FDA approval and launched a complex injectable lanreotide product referencing Somatuline Depot. |
What to Watch | Commercial uptake, pricing and market share within the US lanreotide market. |
Primary Source | Amneal Pharmaceuticals |
Relevant Date | 18 September 2026 |
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