Amneal said the FDA approved its romidepsin injection solution, a ready-to-use vial presentation for adult cutaneous T-cell lymphoma. Wire coverage said the product may qualify for 180 days of Competitive Generic Therapy exclusivity.
Amneal said the U.S. Food and Drug Administration has approved its romidepsin injection solution, a ready-to-use oncology injectable supplied in single-dose vials.
The company said the product is indicated for adult patients with cutaneous T-cell lymphoma who have received at least one prior systemic therapy.
Amneal described the product as a former Teva formulation and said it is eligible for Competitive Generic Therapy designation, which can provide 180 days of market exclusivity.
Wire coverage of the announcement said Amneal cited about $78 million in U.S. annual sales for romidepsin lyophilized powder in the 12 months ended April 2026.
The approval gives Amneal a new hospital-use oncology product in a market where a ready-to-use presentation may be operationally simpler than a reconstituted formulation. The company did not give a commercial launch date in the materials reviewed.
What to watch
The next questions are when Amneal begins commercial shipment and whether FDA listings or related market filings add further detail about the product in the coming days.
Revision note
Initial automated publication.