Amneal Announces U.S. FDA Approval of Romidepsin Injection Solution

Rhea-AI Summary

Amneal (Nasdaq: AMRX) received U.S. FDA approval for its romidepsin injection solution, 27.5 mg/5.5 mL, in ready-to-use single-dose vials. The product is eligible for Competitive Generic Therapy (CGT) designation, providing 180 days of market exclusivity.

The drug is a histone deacetylase inhibitor indicated for adult cutaneous T-cell lymphoma patients after at least one prior systemic therapy. According to IQVIA, U.S. annual sales for romidepsin lyophilized powder were about $78 million for the 12 months ended April 2026.

Positive

• FDA approval of romidepsin injection solution 27.5 mg/5.5 mL
• Eligible for Competitive Generic Therapy with 180 days U.S. exclusivity
• Ready-to-use vials eliminate reconstitution steps for hospitals and pharmacies
• Returns an oncology medicine for cutaneous T-cell lymphoma to the U.S. market
• IQVIA reports approximately $78 million U.S. annual romidepsin sales baseline
• Adds to Amneal’s differentiated, high-value injectables portfolio

Negative

• Common adverse reactions include nausea, fatigue, infections and vomiting
• Grade 3-4 lab abnormalities ≥10% include lymphopenia and neutropenia
• Indication limited to adults with cutaneous T-cell lymphoma after prior systemic therapy

News Market Reaction – AMRX

+5.01%

+5.01% News Effect

On the day this news was published, AMRX gained 5.01%, reflecting a notable positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved +5.0% in the session following this news. A strong positive reaction aligns with Amn...

Analysis

The stock moved +5.0% in the session following this news. A strong positive reaction aligns with Amneal’s strategy of adding complex, high‑value injectables, but past FDA approvals averaged only a -0.37% move, suggesting historically tempered responses. A move well above this range could reflect enthusiasm about the 180-day CGT exclusivity and the $78 million reference market, yet investors would need to weigh execution, competitive dynamics once exclusivity ends, and existing short positioning when assessing durability.

Key Figures

Romidepsin strength: 27.5 mg/5.5 mL Market exclusivity: 180 days Reference product sales: $78 million +2 more

5 metrics

Romidepsin strength 27.5 mg/5.5 mL Injection solution single-dose, ready-to-use vial

Market exclusivity 180 days Competitive Generic Therapy (CGT) designation

Reference product sales $78 million IQVIA U.S. annual sales, 12 months ended April 2026

Treatment line ≥1 prior systemic therapy Indication requirement for cutaneous T-cell lymphoma

Grade 3–4 abnormality threshold ≥10% Frequency threshold for listed hematologic lab abnormalities

Previous Fda approval Reports

5 past events · Latest: Dec 22 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Dec 22	Biosimilars approval	Positive	+0.2%	FDA approval of two denosumab biosimilars referencing Prolia and XGEVA.
Dec 09	Injectable approval	Positive	+2.0%	FDA approval of epinephrine injection vials for hospital and acute care use.
Dec 02	Respiratory generic ok	Positive	-2.5%	FDA approval of albuterol sulfate inhalation aerosol, generic PROAIR HFA.
Dec 01	Ophthalmic approval	Positive	-2.5%	FDA approval of cyclosporine ophthalmic emulsion 0.05%, generic RESTASIS.
Nov 13	Imaging agent approval	Positive	+1.0%	FDA approval of iohexol injection, first generic of Omnipaque.

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

Pattern Detected

Recent FDA approval headlines have produced mixed, generally modest moves, with an average -0.37% reaction and a nearly even split between aligned and divergent price responses.

Recent Company History

Over the past several FDA approval announcements, Amneal has steadily broadened its complex generics and biosimilars portfolio across injectables, respiratory, ophthalmic, and imaging agents. Prior approvals for denosumab biosimilars, epinephrine vials, albuterol inhalation aerosol, cyclosporine ophthalmic emulsion, and iohexol injection showed small, mixed price reactions, averaging -0.37%. Today’s romidepsin injection solution approval continues this strategy of expanding differentiated hospital and specialty offerings, again backed by IQVIA market data on branded reference product sales.

Key Terms

histone deacetylase inhibitor, cutaneous T-cell lymphoma, lyophilized powder, electrocardiogram ST-T wave changes, +4 more

8 terms

histone deacetylase inhibitor medical

"Romidepsin injection solution is a histone deacetylase inhibitor indicated..."

A histone deacetylase inhibitor is a drug that blocks enzymes which tighten DNA’s packaging inside cells, a bit like loosening a tightly wound spool so hidden instructions can be read again; by changing which genes are active, these drugs can restore normal behavior in diseased cells, including some cancers. Investors watch them because clinical trial results, regulatory approvals, safety issues, or commercial uptake can dramatically affect a drug developer’s prospects and therefore its stock value.

cutaneous T-cell lymphoma medical

"indicated for the treatment of cutaneous T-cell lymphoma in adult patients..."

Cutaneous T-cell lymphoma is a rare type of skin cancer that develops when certain immune system cells grow uncontrollably, causing skin patches, rashes, or tumors. While it primarily affects health, its rarity and complexity can influence medical research funding and pharmaceutical development, which may impact investment opportunities in healthcare and biotech sectors. Understanding such diseases helps investors gauge potential risks and innovations in medical treatments.

lyophilized powder medical

"more convenient alternative to lyophilized powder requiring reconstitution"

A lyophilized powder is a drug or biological product that has been freeze-dried into a stable, dry form by removing water under low temperature and pressure. For investors, this matters because freeze-dried products are easier to store, ship, and keep effective longer than liquids, reducing cold-chain costs and spoilage risk; they also indicate extra manufacturing steps and regulatory scrutiny that affect production complexity and margins.

electrocardiogram ST-T wave changes medical

"adverse reactions... include nausea... electrocardiogram ST-T wave changes, dysgeusia..."

Patterns seen on an electrocardiogram that involve the ST segment and T wave, reflecting changes in the heart’s electrical recovery after each beat; they can indicate reduced blood flow, heart muscle stress or injury, electrolyte or drug effects. Investors should notice these findings because they can affect clinical trial safety signals, regulatory decisions, executive health or product liability — like a dashboard warning light that can trigger delays, costs or market reactions.

lymphopenia medical

"Grade 3‐4 laboratory abnormalities (≥ 10%) include lymphopenia, neutropenia..."

Lymphopenia is a lower-than-normal level of lymphocytes, the white blood cells that act like the body's front-line defenders against infections. For investors, it matters because the condition can be a sign of disease or a side effect of a drug or treatment in clinical trials, potentially leading to safety warnings, trial delays, changed labeling or reduced market value; think of it as a red flag showing the immune system may be weakened.

neutropenia medical

"Grade 3‐4 laboratory abnormalities (≥ 10%) include lymphopenia, neutropenia..."

Neutropenia is a medical condition where the blood has an unusually low number of neutrophils, the white blood cells that act like the body’s front-line security guards against bacterial and fungal infections. For investors, it matters because neutropenia can signal safety or tolerability problems for drugs or treatments, driving clinical trial setbacks, regulatory scrutiny, additional monitoring costs, or label warnings that can influence a company’s commercial outlook and stock value. Monitoring for neutropenia is a common part of assessing medical risk and long-term financial impact.

anemia medical

"Grade 3‐4 laboratory abnormalities (≥ 10%) include lymphopenia, neutropenia, anemia..."

A condition in which the blood has fewer red blood cells or less hemoglobin than normal, reducing the blood’s ability to carry oxygen to tissues. Think of it as having fewer delivery trucks or smaller cargo on each trip, so the body’s organs and muscles get less fuel. Investors watch anemia because it can drive demand for drugs, tests and devices, affect patient outcomes in clinical trials, and influence workforce productivity and healthcare costs.

thrombocytopenia medical

"Grade 3‐4 laboratory abnormalities (≥ 10%) include... anemia and thrombocytopenia."

Thrombocytopenia is a medical condition marked by an abnormally low number of platelets, the blood cells that act like a patching crew to stop bleeding. It matters to investors because it can signal safety risks for drugs or procedures, affect clinical trial outcomes, trigger regulatory scrutiny, lead to additional costs or label changes, and influence a company’s stock if treatments must be halted or modified.

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• 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.

Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com

Media Contact
Brandon Skop
Sr. Director, Corporate Communications
brandon.skop@amneal.com

FAQ

What FDA approval did Amneal (AMRX) receive for romidepsin on June 4, 2026?

Amneal received U.S. FDA approval for a romidepsin injection solution, 27.5 mg/5.5 mL, in ready-to-use vials. According to Amneal, this formulation is a histone deacetylase inhibitor for adults with cutaneous T-cell lymphoma after at least one prior systemic therapy.

What is the Competitive Generic Therapy exclusivity for Amneal romidepsin (AMRX)?

Amneal’s romidepsin injection solution is eligible for Competitive Generic Therapy designation, providing 180 days of market exclusivity. According to Amneal, this CGT status also reinforces its position in complex, high-value generics and expands its differentiated injectable medicines portfolio in the United States.

How does Amneal’s romidepsin injection differ from lyophilized powder products?

Amneal’s romidepsin is a ready-to-use injection solution supplied in single-dose vials, eliminating reconstitution. According to Amneal, this can reduce preparation complexity, support more accurate dosing, and offer safety and operational advantages versus lyophilized powder requiring multiple preparation steps in hospitals and pharmacies.

What condition is Amneal romidepsin injection solution (AMRX) approved to treat?

Romidepsin injection solution is approved to treat cutaneous T-cell lymphoma in adults who received at least one prior systemic therapy. According to Amneal, the drug is a histone deacetylase inhibitor that brings an established oncology option back to the U.S. treatment landscape.

What are the main side effects of Amneal romidepsin injection solution?

Common adverse reactions include nausea, fatigue, infections, vomiting, anorexia, ECG ST-T changes, dysgeusia, constipation and pruritus. According to Amneal, Grade 3-4 laboratory abnormalities (≥10%) include lymphopenia, neutropenia, anemia and thrombocytopenia, underscoring the need for monitoring during treatment.

What is the U.S. market size for romidepsin referenced in the Amneal (AMRX) approval?

According to IQVIA, U.S. annual sales for romidepsin lyophilized powder in single-dose vials were about $78 million for the 12 months ended April 2026. This sales figure provides a reference market baseline for Amneal’s newly approved romidepsin injection solution product.

How does the romidepsin injection approval support Amneal’s injectable portfolio strategy?

The romidepsin approval adds a differentiated oncology injectable to Amneal’s growing hospital-focused portfolio. According to Amneal, it strengthens the company’s presence in complex, high-value injectables and supports goals to expand access, enhance supply reliability and help providers deliver optimal patient care.