FDA Accepts Merck & Co.’s NDA for HIV Fixed Dose Combination

Merck & Co. reports that the US Food and Drug Administration (FDA) has accepted the company’s new drug application for a fixed-dose combination of raltegravir with lamivudine for the treatment of HIV-1 infection.

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 new FDC contains a new formulation of raltegravir. 

Isentress is Merck’s integrase inhibitor for the treatment of HIV-1 infection in adult and pediatric patients ages four weeks and older and weighing at least 3 kg as part of combination HIV therapy. Merck is continuing to move forward with filings of Isentressfor oral suspension in additional countries around the world.

Source: Merck & Co.

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