Merck, known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for a fixed-dose combination (FDC) of raltegravir with lamivudine for the treatment of HIV-1 infection (MK-0518B) has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck is seeking FDA approval for 150 mg lamivudine/300 mg raltegravir, in combination with other antiretroviral agents, for the treatment of HIV-1 in adults, adolescents (16 years of age and older) and pediatric patients (6 through 16 years of age and weighing at least 30 kg).  Raltegravir is currently marketed as Isentress in the United States. Several different formulations of Isentress are currently available, including a film-coated tablet (400 mg), chewable tablets (25 mg and 100 mg) and oral suspension (single use 100-mg packet). The MK-0518B FDC contains a new formulation of raltegravir. 

For more details, go to: http://www.mercknewsroom.com/news-release/research-and-development-news/fda-accepts-mercks-nda-fixed-dose-combination-raltegravir