FDA Approves Amneal's Generic Romidepsin Injection for Cutaneous T-Cell Lymphoma

The U.S. Food and Drug Administration has approved Amneal Pharmaceuticals' ready-to-use generic romidepsin injection solution. This medication is indicated for adult patients with cutaneous T-cell lymphoma who have previously undergone at least one systemic therapy. Amneal will receive 180 days of market exclusivity for this product under the Competitive Generic Therapy designation.