Amneal Pharmaceuticals, Inc. (AMRX), a commercial-stage biopharmaceutical company, announced on Thursday that the U.S. Food and Drug Administration, or FDA, has approved a 27.5 mg/5.5 mL Romidepsin injection solution as a single-dose supply in a ready-to-use vial for the treatment of cutaneous T-cell lymphoma.
Amneal Pharmaceuticals is a commercial-stage biopharmaceutical company that is focused on the development, manufacture, and commercialization of generic medicines, specialty pharmaceuticals, injectables, and biosimilars.
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.
Amneal's formulated Romidepsin injection solution is a reference formulation of a former Romidepsin solution previously marketed by Teva that was withdrawn from the market several years ago.
Earlier then, Romidepsin solution marketed by Teva under a 505(b)(2) approval relied upon Celgene's NDA for ISTODAX (romidepsin).
Following the failure of the regulatory-required confirmatory post-marketing Ro-CHOP trial by Celgene to demonstrate a progression-free survival benefit in PTCL, Celgene withdrew the peripheral T-cell lymphoma, or PTCL, indication for ISTODAX, and Teva subsequently removed the same indication from its Romidepsin product through a labelling supplement.
According to Amneal, currently the approved Romidepsin injectable is eligible for a Competitive Generic Therapy, or CGT, designation that provides 180 days' market exclusivity for Amneal.
Amneal noted, according to IQVIA, for the 12 months ended in April 2026, U.S.-based annual sales of Romidepsin lyophilized powder in single-dose vials were approximately $78 million.
Arash Dabestani, Vice President, Institutional, commented, "The 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."
Amneal has traded between $7.07 and $15.42 over the last year. Amneal shares closed Thursday at $13.52, up 5.01%.
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