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Onco-Summaries: Daily Oncology Updates at a Glance


04/06/2026










Amneal secures FDA nod and 180‑day CGT exclusivity for ready‑to‑use romidepsin injection in cutaneous T‑cell lymphoma (Ref)


Amneal received US FDA approval for its romidepsin injection solution (27.5 mg/5.5 mL), supplied in ready-to-use vials


Competitive Generic Therapy (CGT): The product qualifies for CGT designation, granting 180 days of market exclusivity. Amneal leads the industry in CGT approvals since 2018

Product Background: This formulation references Teva’s earlier romidepsin solution, which was withdrawn from the market years ago


Advantages: Ready-to-use format eliminates reconstitution steps, improving safety and operational efficiency for hospitals and pharmacies


Oncology Indication: Romidepsin is a histone deacetylase inhibitor indicated for cutaneous T-cell lymphoma in adults after at least one prior systemic therapy



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