Amneal Pharmaceuticals' Romidepsin Injection Solution Wins FDA Approval

(RTTNews) - Thursday, Amneal Pharmaceuticals, Inc. (AMRX) announced that the U.S. Food and Drug Administration has approved the company's ready-to-use romidepsin injection solution.

The product 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.

Following this approval, romidepsin injection solution is now eligible for Competitive Generic Therapy designation, which provides Amneal with 180 days of market exclusivity.

The approval also reflects the company's continued focus on addressing meaningful needs for hospitals and providers.

In the pre-market hours, AMRX is trading at $13.19, up 2.45 percent on the Nasdaq.