- Ready-to-use romidepsin formulation; offers a more convenient alternative to lyophilized powder requiring reconstitution
- Competitive Generic Therapy approval provides 180 days of market exclusivity and further expands Amneal's differentiated injectables portfolio
BRIDGEWATER, N.J., June 04, 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 the Company's romidepsin injection solution, 27.5 mg/5.5 mL, supplied in single-dose, ready-to-use vials.
The product is eligible for Competitive Generic Therapy (CGT) designation, which provides Amneal with 180 days of market exclusivity. Since the FDA began tracking CGT approvals in 2018, Amneal has received the most CGT approvals in the industry, demonstrating its leadership in bringing complex and high-value medicines to market. Romidepsin injection solution references the former romidepsin solution formulation previously marketed by Teva, which was withdrawn from the market several years ago.
"Ready-to-use presentations such as our romidepsin injection solution can offer important safety and operational advantages for hospitals and pharmacies by eliminating reconstitution steps, helping reduce preparation complexity and supporting more accurate and consistent preparation for patients," said Arash Dabestani, Pharm.D., Senior Vice President, Institutional. "This approval brings an important oncology medicine back to the market and reflects Amneal's continued focus on addressing meaningful needs for hospitals and providers. It also builds on our growing injectables business, where we are committed to delivering high-value, differentiated products that expand access, strengthen supply reliability and support providers in delivering optimal care."
Romidepsin injection solution is a histone deacetylase inhibitor indicated for the treatment of cutaneous T-cell lymphoma in adult patients who have received at least one prior systemic therapy.
The most common adverse reactions associated with romidepsin injection solution include nausea, fatigue, infections, vomiting, anorexia, electrocardiogram ST-T wave changes, dysgeusia, constipation and pruritus. Grade 3-4 laboratory abnormalities (= 10%) include lymphopenia, neutropenia, anemia and thrombocytopenia. Please see full Prescribing Information here.
According to IQVIA U.S. annual sales for romidepsin lyophilized powder in single-dose vials for the 12 months ended April 2026 were approximately $78 million.
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. Founded in 2002 by brothers and co-CEOs Chirag and Chintu Patel, Amneal was built on the belief that innovation only matters if it's accessible. Today, Amneal has a diverse and growing portfolio of approximately 300 complex, specialty and biosimilar medicines, delivering over 160 million prescriptions each year, primarily in the United States. Our Affordable Medicines segment spans retail, injectable, and biosimilar products. 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 more information, please visit www.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.
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Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com
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Sr. Director, Corporate Communications
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