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Amneal Announces FDA Approval and Launch of Lanreotide Injection

  • Amneal Pharmaceuticals received FDA approval for lanreotide injection 120 mg/0.5 mL in a sterile, single-dose prefilled syringe.
  • The product references SOMATULINE ® Depot & received Competitive Generic Therapy (CGT) designation from the FDA.
  • Immediate commercial launch is supported by Amneal's in-house production capabilities.
  • Lanreotide injection is indicated for treating acromegaly, advanced gastro-enteropancreatic neuroendocrine tumors (GEP-NETs), & carcinoid syndrome.
  • U.S. annual sales for the reference product SOMATULINE ® Depot reached $983 million for the 12 months ended July 2026.
  • Amneal's Affordable Medicines segment views this approval as a material growth driver for its complex injectables portfolio.