Amneal Pharmaceuticals, Inc. ("Amneal" or the "Company") (NASDAQ:AMRX) today announced that the U.S. Food and Drug Administration (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injection solution references the former romidepsin solution formulation previously marketed by Teva, which was withdrawn from the market several years ago.