16-02-2017 11:20 via genengnews.com

Valeant Psoriasis Drug Gets FDA Nod with Boxed Warning

FDA approved Valeant Pharmaceuticals’s injectable plaque psoriasis therapy, Siliq (brodalumab), but with a black box warning of suicidal ideation and behaviour. Siliq availability will also be restricted through a Risk Evaluation and Mitigation Strategy (REMS) program. "Patients and their health care providers should discuss the benefits and risks of Siliq before considering treatment,” said Julie Beitz, M.D., director of FDA’s Office of Drug Evaluation III, Center for Drug Eva
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