VFEND

FDA-2023-P-5094

Cardinal Health Regulatory Sciences filed an amendment to a suitability petition regarding Voriconazole Injection, submitting an Initial Pediatric Study Plan (iPSP) in response to an FDA information request. The petition addresses regulatory requirements for pediatric study obligations under applica

FDA-2023-P-5094

This petition from Cardinal Health Regulatory Sciences requests FDA suitability assessment for voriconazole products referencing the RLD VFEND, with the submission including the August 2022 version of the VFEND label from the FDA's drugs database.

FDA-2021-P-0342

Cardinal Health Regulatory Sciences filed a suitability petition requesting FDA approval of model labeling for VFEND (voriconazole), the reference listed drug, to establish appropriate labeling standards for generic versions of this antifungal medication. The petition sought to facilitate the develo

FDA-2021-P-0342

Cardinal Health Regulatory Sciences filed a suitability petition regarding VFEND (voriconazole) requesting FDA carved exclusivity information based on the reference listed drug model label, seeking to establish regulatory pathways for generic or alternative formulations through exclusivity determina

FDA-2021-P-0342

Cardinal Health Regulatory Sciences filed a suitability petition regarding VFEND (voriconazole), the reference listed drug, requesting FDA evaluation of the appropriateness of using VFEND's approved labeling as a basis for developing generic formulations of voriconazole under the ANDA pathway.