Ketoconazole Oral Tablets & Drug Use Trends after Safety Label Change and Use in Labeled Indications

Details

Basic Details

Status

Complete

Last Updated

Monday, December 4, 2017

Health Outcome(s)

drug use trends after safety label change and use in labeled indications

Purpose

Drug Use

Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR

No

Regulatory Determination / Use

Citizen Petition Response

Result(s) (1)

Indications of Use Among Oral Antifungal Drug Users

Regulatory Link(s) (1)

Letter from FDA (Docket No. FDA-2015-P-0578)