FDA Extends Review Timeline For STELARA(TM) (ustekinumab) Biologic License Application By Three Months
May 28th, 2009 | By buddy1 | Category: 26, Health & Wellness News, Skin Care & DermatologyCentocor Ortho Biotech Inc. announced that the U.S. Food and Drug Administration (FDA) has extended by three months the review timeline for the Biologic License Application (BLA) for STELARA(TM) (ustekinumab) to provide time for a full review of an amendment to the pending application. The application seeks approval to market STELARA for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
