FDA Accepts Merck’s NDA for Fixed-Dose Combination of Raltegravir with Lamivudine | Merck Newsroom Home

Merck (NYSE: MRK), 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 (ARV) 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.



FDA Accepts Merck’s NDA for Fixed-Dose Combination of Raltegravir with Lamivudine | Merck Newsroom Home