FDA Approves Amneal’s Ready-to-Use Generic Romidepsin Injection Solution for Cutaneous T-Cell Lymphoma – Amneal
Amneal Pharmaceuticals announced that the 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injection solution references the former romidepsin solution formulation previously marketed by Teva, which was withdrawn from the market several years ago.
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.
