Minocycline

FDA Drug Profile — ZILXI, AMZEEQ

Drug Details

Generic Name
Minocycline
Brand Names
ZILXI, AMZEEQ
Application Number
NDA213690
Sponsor
Journey Medical Corporation
NDC Codes
2
Dosage Forms
AEROSOL, FOAM
Routes
TOPICAL
Active Ingredients
MINOCYCLINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE ZILXI is indicated for the treatment of inflammatory lesions of rosacea in adults [see Clinical Studies ( 14 )] . Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated [see Warnings and Precautions ( 5.14 )] . ZILXI is a tetracycline-class drug indicated for the treatment of inflammatory lesions of rosacea in adults. ( 1 ) Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated ( 1 ).