Minocycline Hydrochloride Extended-Release

FDA Drug Profile — EMROSI

Drug Details

Generic Name
Minocycline Hydrochloride Extended-Release
Brand Names
EMROSI
Application Number
NDA219015
Sponsor
Journey Medical Corporation
NDC Codes
1
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
MINOCYCLINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE EMROSI is indicated to treat inflammatory lesions (papules and pustules) of rosacea in adults. Limitations of Use This formulation of minocycline has not been evaluated in the treatment or prevention of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use EMROSI only as indicated. EMROSI is a tetracycline-class drug indicated to treat inflammatory lesions (papules and pustules) of rosacea in adults. ( 1 ) Limitations of Use This formulation of minocycline has not been evaluated in the treatment or prevention of infections. To reduce the development of drug-resistant bacteria and to maintain the effectiveness of other antibacterial drugs, use EMROSI only as indicated. ( 1 )