oteseconazole

FDA Drug Profile — VIVJOA

Drug Details

Generic Name
oteseconazole
Brand Names
VIVJOA
Application Number
NDA215888
Sponsor
Mycovia Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
OTESECONAZOLE

Indications and Usage

1 INDICATIONS AND USAGE VIVJOA™ is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. ( 1 ) 1.1 Vulvovaginal Candidiasis VIVJOA is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential [see Warnings and Precautions (5.1) , Use in Specific Populations (8.3) , and Clinical Studies (14) ] . 1.2 Usage If specimens for fungal culture are obtained prior to therapy, antifungal therapy may be instituted before the results of the cultures are known. However, once these results become available, antifungal therapy should be adjusted accordingly.