Amneal Announces FDA Approval and Launch of Lanreotide Injection

FDA approval and immediate launch of lanreotide injection adds a new complex injectable to Amneal’s portfolio in a nearly $1 billion U.S. market.

Rhea-AI Summary

Amneal Pharmaceuticals (AMRX) received U.S. FDA approval for its 120 mg/0.5 mL lanreotide injection in a sterile, single-dose prefilled syringe and is launching the product immediately.

The drug references SOMATULINE® Depot, which recorded U.S. annual sales of $983 million for the 12 months ended July 2026, per IQVIA. The lanreotide product has been granted Competitive Generic Therapy (CGT) designation by the FDA. Amneal highlights that the approval and launch will be a material growth driver for its Affordable Medicines business and a notable addition to its expanding complex injectables portfolio.

The company states that its dedicated, large-scale in-house manufacturing capacity is expected to support reliable market supply and broaden access. Lanreotide Injection is indicated for the treatment of acromegaly, advanced gastro-enteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome, helping to control hormone levels, improve progression-free survival in eligible GEP-NET patients, and reduce the need for rescue therapy in carcinoid syndrome.

Positive

• Lanreotide injection FDA approval with immediate U.S. commercial launch
• References SOMATULINE Depot with U.S. sales of $983 million for 12 months ended July 2026
• Product holds FDA Competitive Generic Therapy (CGT) designation
• Large-scale in-house manufacturing capacity expected to support reliable supply

Negative

• None.

Argus 15 min delay

+1.02% vs previous close $18.90 last price 4.7x rel. volume Open Argus

Details

Market Reaction – AMRX

$18.07 $18.90 Day Range

$6.58B Market Cap

Following this news, AMRX has gained 1.02%, reflecting a mild positive market reaction. Our momentum scanner has triggered 4 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $18.90. Trading volume is very high at 4.7x the average, suggesting strong buying interest.

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Market Context

On June 4, 2026, a comparable FDA approval was followed by a 5.01% 24-hour gain for AMRX. That romid...

Analysis

On June 4, 2026, a comparable FDA approval was followed by a 5.01% 24-hour gain for AMRX. That romidepsin precedent contextualized today's FDA approval and immediate launch, while the broader approval record remained mixed.

Key Figures

Lanreotide dosage: 120 mg/0.5 mL Reference product annual sales: $983 million

Lanreotide dosage

120 mg/0.5 mL

Sterile, single-dose prefilled syringe

Reference product annual sales

$983 million

U.S. SOMATULINE Depot sales for the 12 months ended July 2026

Previous Fda approval Reports

5 past events · Latest: Jul 17

Same Type 5 events

1. Jul 17

   FDA approval

   24h Move

   -1.1%

   FDA approved additional iohexol injection strengths and vial presentations

2. Jun 04

   FDA approval

   24h Move

   +5.0%

   FDA approved romidepsin injection eligible for Competitive Generic Therapy designation

3. Dec 22

   FDA approval

   24h Move

   +0.2%

   FDA approved denosumab biosimilars referencing Prolia and XGEVA

4. Dec 09

   FDA approval

   24h Move

   +2.0%

   FDA approved epinephrine injection single-dose and multi-dose vial presentations

5. Dec 02

   FDA approval

   24h Move

   -2.5%

   FDA approved albuterol sulfate inhalation aerosol for U.S. commercialization

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

competitive generic therapy, progression-free survival, gep-nets, prefilled syringe

4 terms

competitive generic therapy regulatory

"received Competitive Generic Therapy (CGT) designation from the FDA"

A competitive generic therapy (CGT) is an FDA regulatory designation for an off‑patent or otherwise unprotected drug for which there is little or no effective generic competition. The designation signals that regulators will provide incentives—such as expedited review or reduced fees—to encourage development of a lower‑cost alternative; for investors it highlights a clearer, potentially faster path to market and a stronger commercial opportunity for the first successful generic entrant, like giving a new product a head start in a race.

progression-free survival medical

"improves progression-free survival in eligible GEP-NET patients"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

gep-nets medical

"advanced gastro-enteropancreatic neuroendocrine tumors (GEP-NETs)"

GEP‑NETs are tumors that develop from hormone-producing cells in the digestive tract and pancreas; they can grow slowly or behave unpredictably and may release hormones that affect the whole body. For investors, they matter because their diagnosis, treatment and size of the patient population influence demand for specific drugs, clinical trial progress, regulatory approval and potential revenue, much like a niche but growing market for specialized products.

prefilled syringe technical

"in a sterile, single-dose prefilled syringe"

A prefilled syringe is a single-use, sterile syringe that comes already filled with a precise dose of a medication or vaccine, ready for immediate use like a pen already loaded with ink. For investors, they matter because they simplify administration, reduce dosing errors, and speed up care, which drives demand, can command higher margins, and ties into regulatory approvals, manufacturing capacity and supply-chain stability—factors that affect a health company's revenue and risks.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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 - 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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What indications is Amneal’s lanreotide injection approved to treat?

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.

What is notable about the dosage form of Amneal’s lanreotide product?

The approved lanreotide injection is a 120 mg/0.5 mL formulation supplied in a sterile, single-dose prefilled syringe, which is the presentation cleared for commercial launch.

How does Amneal describe the strategic importance of this approval?

The company describes lanreotide as a material growth driver for its Affordable Medicines business and a significant addition to its expanding complex injectables portfolio, reflecting the strength of its integrated development and manufacturing capabilities.

Where can healthcare providers find the full prescribing information for lanreotide injection?

The full prescribing information is available in the package insert, which the company directs readers to consult for complete details.