FDA grants priority review to GSK’s Promacta sNDA for treatment of thrombocytopenia

Published on July 26, 2012 at 1:43 AM · No Comments

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that its partner GlaxoSmithKline (NYSE: GSK) has been granted priority review from the US Food and Drug Administration for the supplemental new drug application for Promacta® to treat thrombocytopenia in adult patients with chronic hepatitis C virus (HCV) infection.

A Priority Review designation is given to drugs that if approved, offer major advances in treatment, or provide a treatment where no adequate therapy exists. Under the Prescription Drugs User Fee Act, the goal for completing a Priority Review is six months.    

Source: Ligand Pharmaceuticals Incorporated

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