Amneal Announces FDA Approval and Launch of Lanreotide Injection
- Expands complex injectables portfolio with important long-acting oncology treatment
- Immediate commercial launch supported by in-house production
BRIDGEWATER, N.J., Sept. 18, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) today announced 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.
“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.
For full prescribing information, see package insert here.
Note: SOMATULINE® Depot is a registered trademark of Ipsen Pharma S.A.S.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, New Jersey, is a diversified, global biopharmaceutical leader focused on expanding access to affordable and innovative medicines. Amneal was founded in 2002 by brothers and co-CEOs Chirag and Chintu Patel, and built on the belief that innovation only matters if it’s accessible. Today, Amneal has a diverse and growing portfolio of approximately 300 complex generic, specialty and biosimilar medicines, delivering more than 160 million prescriptions annually, primarily in the United States. Our Affordable Medicines segment spans retail generics, injectables, and biosimilars. Our Specialty segment provides branded treatments in neurology, including Parkinson’s disease and migraine, and endocrinology. Our AvKARE segment distributes pharmaceuticals and medical products to U.S. federal, retail, and institutional customers. For additional information, please visit amneal.com and follow us on LinkedIn.
Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com
Media Contact
Brandon Skop
Sr. Director, Corporate Communications
brandon.skop@amneal.com
