maraviroc

FDA Drug Profile — SELZENTRY

maraviroc is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including SELZENTRY. Available dosage forms: tablet, film coated, kit.

Drug Details

Generic Name
maraviroc
Brand Names
SELZENTRY
Application Number
NDA022128
Sponsor
ViiV Healthcare Company
NDC Codes
4
Dosage Forms
TABLET, FILM COATED, KIT
Routes
ORAL
Active Ingredients
MARAVIROC

Indications and Usage

1 INDICATIONS AND USAGE Maraviroc tablets are indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients 2 years of age and older weighing at least 10 kg. Limitations of Use: • Maraviroc tablets are not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1 [ see Microbiology ( 12.4 ) ]. Maraviroc tablet is a CCR5 co-receptor antagonist indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. ( 1 ) Limitations of Use: • Not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1. ( 1 )