Amneal Pharmaceuticals (NASDAQ:AMRX) said on Thursday the US Food and Drug Administration has approved its romidepsin injection solution, 27.5 mg/5.5 mL, in single-dose, ready-to-use vials.
The product is eligible for Competitive Generic Therapy (CGT) designation, giving Amneal 180 days of market exclusivity. The New Jersey-based company said it has received more CGT approvals than any other company since the FDA began tracking the designations in 2018.
The ready-to-use formulation references a romidepsin solution previously marketed by Teva that was withdrawn from the market several years ago. Annual U.S. sales of romidepsin lyophilized powder in single-dose vials reached approximately $78 million for the 12 months ended April 2026, according to IQVIA data.
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.
"This approval brings an important oncology medicine back to the market," said Arash Dabestani, Senior Vice President, Institutional, adding that the product reflects the company's focus on its growing injectables business and addressing needs for hospitals and providers.
Amneal shares were up 5.1% on Thursday.