FDA Extends Review Timeline For STELARA(TM) (ustekinumab) Biologic License Application By Three Months
Centocor 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 [...]
Also tagged Adult Patients, Bla, Fda, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, License Application, Plaque Psoriasis, Psoriasis, Severe Plaque Psoriasis, Systemic Therapy, Three Months
