RYDAPT

批准信原文要点

This Prior Approval sNDA provides for revisions to the U.S. Prescribing Information, Postmarketing Experience Section 6.2, to add acute febrile neutrophilic dermatosis (Sweet Syndrome).

批准信原文要点

This Prior Approval sNDA provides for the following changes: Revisions to the Rydapt® United States Prescribing Information (USPI) to reflect the most up to date information with respect to midostaurin’s drug-drug interaction potential.

批准信原文要点

This Prior Approval supplemental new drug application provides for: Revisions to the Rydapt United States Prescribing Information (USPI) to include electrogram QT prolonged to Table 2, pneumonitis in other clinically important adverse reactions under Section 6.1 Clinical Trial…

批准信原文要点

This Prior Approval supplemental new drug application provides for revisions to the Rydapt (midostaurin) United States Prescribing Information (UPSI) based on a review of safety findings in pediatric patients with acute myeloid leukemia in Study CPKC412A2218.

批准信原文要点

This Prior Approval supplemental new drug application provides for the removal of VEGFR2 from subsection 12.1 Mechanism of Action and minor editorial changes to the label for midostaurin.

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to the labeling under Section 8.1 Pregnancy and Section 17 Patient Counseling Information to provide notice of the Pregnancy Surveillance Program and telephone contact numbers and website. In addition, there are updates to the molecular description of midostaurin, Section 11 Description and drug-drug interaction information under section 12.3 Pharmacokinetics.