Additional Relevant Details
Valeant has received notification from the U.S. Food and Drug Administration (FDA) that the Dermatologic and Ophthalmic Drugs Advisory Committee will review Valeant's New Drug Application (NDA) for brodalumab on July 19, 2016.On January 25, 2016, Valeant announced that the FDA had accepted for review the Biologics License Application (BLA) submitted by AstraZeneca (LSE/SSE/NYSE: AZN) in partnership with Valeant for brodalumab injection, 210 mg, a monoclonal antibody that targets the IL-17 receptor, in development for patients with moderate to severe plaque psoriasis. The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016.