On September 18, 2026 Amneal Pharmaceuticals, Inc. ("Amneal" or the "Company") (NASDAQ: AMRX) reported that the U.S. Food and Drug Administration (FDA) has approved its lanreotide injection, 120 mg/0.5 mL, in a sterile, single-dose prefilled syringe. The product references SOMATULINE Depot and will launch immediately. The product received Competitive Generic Therapy (CGT) designation from the FDA.
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"The approval and launch of lanreotide adds another material growth driver to our Affordable Medicines business," said Srinivas Kone, Ph.D., Senior Vice President and Chief Scientific Officer – Affordable Medicines. "Lanreotide is a significant addition to our expanding complex injectables portfolio and reflects the strength of our integrated development and manufacturing capabilities. With dedicated, large-scale in-house manufacturing capacity, we are well positioned to reliably supply the market, broaden access to this important medicine and create meaningful long-term value for patients, providers, and shareholders."
U.S. annual sales for SOMATULINE Depot for the 12 months ended July 2026 were $983 million, per IQVIA.
Lanreotide Injection is indicated for: the treatment of acromegaly, advanced gastro-enteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome. It helps control hormone levels in acromegaly, improves progression-free survival in eligible GEP-NET patients, and reduces the need for rescue therapy in patients with carcinoid syndrome.
(Press release, Amneal Pharmaceuticals, SEP 18, 2026, View Source [SID1234670956])