OJEMDA

批准信原文要点

Prior Approval sNDA 002 provides for updates ... based on ... FIREFLY-1; and references the availability of an FDA-approved companion diagnostic. "Changes Being Effected" sNDA 003 provides for a new 20 count carton configuration ... Prior Approval sNDA 004 provides for updates ... based on data from a carcinogenicity study ... to fulfill postmarketing requirement 4608-2.

批准信原文要点

Prior Approval sNDA 002 provides for updates ... FIREFLY-1; and references the availability of an FDA-approved companion diagnostic. "Changes Being Effected" sNDA 003 provides for a new 20 count carton configuration ... Prior Approval sNDA 004 provides for updates ... carcinogenicity study ... PMR 4608-2.

批准信原文要点

Prior Approval sNDA 002 provides for updates to the U.S. Prescribing Information (USPI) and Patient Information labeling, based on safety and efficacy data generated from Study DAY101-001/PNOC026 (FIREFLY-1); and references the availability of an FDA-approved companion diagnostic. “Changes Being Effected” sNDA 003 provides for a new 20 count carton configuration comprised of four blister cards each containing five 100 mg tablets to support the 500 mg once weekly dose packaging configuration. Prior Approval sNDA 004 provides for updates to the USPI labeling, based on data from a carcinogenicity study … to fulfill postmarketing requirement 4608-2.

批准信原文要点

This “Changes Being Effected” sNDA provides for • Section 8.6 Hepatic Impairment: typographical error (alanine aminotransferase [AST] was revised to aspartate aminotransferase [AST]). • Section 11 DESCRIPTION the proprietary name Opadry® was replaced with the ingredient “orange”. • Patient Information and Instructions For Use were revised for consistency with the USPI.