Valeant Drug Should Be Approved With Risk Plan, FDA Advisers Say

Valeant Drug Should Be Approved With Risk Plan, FDA Advisers Say


Valeant Pharmaceuticals International Inc. won the backing of a panel of U.S. regulatory advisers who supported approval of its experimental psoriasis treatment, on the condition that the company takes extra steps to help mitigate possible suicide risk associated with the drug. Food and Drug Administration advisers voted Tuesday to recommend that the agency clear the drug, brodalumab, for sale with the risk-management plan and a label that warns it may be linked to a higher risk of suicide.



from Biotech News