FDA Rejects NDA for Extended-Release Jakafi - Managed Healthcare Executive

Key claim: The FDA issued a complete response letter rejecting Incyte’s NDA for an extended-release formulation of ruxolitinib (Jakafi) for myelofibrosis, polycythemia vera, and graft-versus-host disease.

Abstract

The FDA issued a complete response letter for ruxolitinib extended-release tablets for myelofibrosis, polycythemia vera, and graft-versus-host disease, though Incyte remains committed to advancing care for MPN patients.

Why this matters

Pending synthesis.

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