Incyte (INCY) Issued FDA CRL for Ruxolitinib Extended-Release Tablets
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Incyte Provides Regulatory Update on Ruxolitinib Extended-Release Tablets
March 23, 2023 8:55 PM EDTWILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for ruxolitinib extended-release (XR) tablets, a JAK1/JAK2 inhibitor, for once-daily (QD) use in the treatment of certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD).
The complete response letter states that the FDA cannot approve the application in its present form. The FDA acknowledged that the study submitted in the New Drug Application (NDA) met its objective of bioequivalence based on area under the... More
