ORGOVYX

批准信原文要点

This Prior Approval sNDA provides for updates to the Prescribing Information including updated lactation information in Section 8.2 based on the final Clinical Study Report (CSR) for Study MVT-601-062, as well as corresponding editorial revisions throughout.

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to Drug Interactions (Section 7), Clinical Pharmacology (Section 12), Clinical Studies (Section 14), and Patient Counseling Information (Section 17) of the USPI, based on Drug-Drug Interaction study data.

批准信原文要点

This “Changes Being Effected” sNDA provides for the addition of postmarketing adverse events for angioedema and urticaria, addition of a Warning and Precaution for hypersensitivity, and addition of a contraindication for patients with known severe hypersensitivity to relugolix.