FDA Approves New Labeling For ISENTRESS® To Include 96-Week Efficacy And Tolerability Data In Adult Patients Infected With HIV-1

August 6, 2010 – 7:21 pm

Merck announced today that the U.S. Food and Drug Administration (FDA) has approved a labeling update for ISENTRESS® (raltegravir) tablets to include 96-week data, which demonstrates the durable efficacy of ISENTRESS in HIV-1 infected patients. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. The new labeling for ISENTRESS is based on analyses of plasma HIV-1 RNA levels through 96 weeks in three double-blind controlled clinical studies of ISENTRESS…




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