Beraprost Sodium

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injection solution references the former romidepsin solution formulation previously marketed by Teva, which was withdrawn from the market several years ago.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 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

Teva’s VP of business development, Evan Lippman talks Pharmaceutical Technology through Teva’s dealmaking and future growth strategy. Credit: Jonathan Weiss / Shutterstock.com. Teva Pharmaceuticals will acquire neuroscience specialist, Emalex – a move which Teva executive, Evan Lippman, says effectively complements the company’s wider “pivot to growth” strategy. Through this agreement, which will set Teva back $700m upfront and up to $200m in potential milestones, the biopharma company will absorb Emalex’s neurology-focused pipeline. This includes ecopipam , Emalex’s first-in-class therapy for paediatric Tourette’s syndrome, which has already secured a Phase III win . With this positive data in hand, Emalex is looking to file for ecopipam’s approval in the US during the second half of 2026 – meaning it could reach the market by “early next year”, Teva’s executive VP of business development, Evan Lippman, tells Pharmaceutical Technology . If it were to secure the US regulatory greenlight, it would become the first new addition to the Tourette’s market in over a decade – succeeding Otsuka and Lundbeck’s second-generation antipsychotic, Abilify (aripiprazole). Differentiating in the Tourette’s market Unlike Abilify and other US-approved paediatric Tourette’s medicines on the market, which target the dopamine 2 (D2) receptor, ecopipam targets D1 – a mechanism that Lippman says could present a more attractive option to patients due to its potentially improved efficacy, tolerability and safety profile. “Ecopipam is a late-stage asset that fits right within our core interest in neuroscience,” Lippman says. “More broadly, it’s a differentiated asset with an orphan drug designation in an area of high unmet need. We felt this [Emalex acquisition] was an excellent fit, given our expertise in the commercial, development and regulatory setting,” he adds. The drug could also fill unmet needs within the paediatric patient population, as Lippman notes that only around 30% of drug-treated patients remain on therapy due to “limitations”. In a research note, Jefferies analysts said that, once approved, ecopipam “should boost Teva’s margin profile and could reach $1bn in US peak sales, assuming 2035 loss of exclusivity”. They add that the drug will likely be positioned in the refractory setting post-antipsychotics, where Teva holds “more pricing power”. Teva hunkers down on growth strategy Teva’s acquisition comes amid the burgeoning success of its innovative medicines portfolio, which demonstrated year-on-year growth of 41% in Q1 2026. According to Lippman, this allows Teva to be strategic and calculated with its dealmaking as the company seeks out pipeline and portfolio-building opportunities. “We do not have an upcoming patent cliff or a burning platform need. So, when we’re looking at acquisitions, we intend to be very thoughtful and precise,” he comments. When on the hunt for new assets, Lippman notes that Teva is primarily seeking late-stage, de-risked and differentiated assets across its two core focus areas of neurology and inflammation – including therapies for rare indications within these categories. While the New Jersey-based pharma will stick with this approach for now, Lippman did add that Teva will look at earlier opportunities in the future.