cobicistat

FDA Drug Profile

cobicistat is listed in the FDA National Drug Code directory with 2 NDC codes. Available dosage forms: powder, tablet, film coated.

Drug Details

Generic Name
cobicistat
Brand Names
N/A
Application Number
Sponsor
Yuhan Chemical
NDC Codes
2
Dosage Forms
POWDER, TABLET, FILM COATED
Routes
N/A
Active Ingredients
COBICISTAT

Indications and Usage

1 INDICATIONS AND USAGE PREZCOBIX is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V). PREZCOBIX is a two-drug combination of darunavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a CYP3A inhibitor, and is indicated for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V). ( 1 )