Isentress Once Daily FDA Approval Pending
(Oct 25 2016) The FDA accepted for review a supplemental NDA for a once-daily formulation of ISENTRESS (raltegravir) in combination with other antiretroviral therapies for the treatment of HIV-1 infection in previously untreated patients or patients whose virus remains suppressed after treatment with an initial regimen of 400 mg of ISENTRESS twice-daily. The FDA granted a PDUFA action date of May 27, 2017.....
Subgroup Analyses from ONCEMRK, a Phase 3 Study of Raltegravir (RAL) 1200 mg Once Daily vs RAL 400 mg Twice Daily, in Combination with Tenofovir/Emtricitabine, in Treatment-Naïve HIV-1 Infected Subjects
Raltegravir (RAL) 1200 mg Once Daily (QD) is Non-Inferior to RAL 400 mg Twice Daily (BID), in Combination with Tenofovir/Emtricitabine, in Treatment-Naïve HIV-1 Infected Subjects: Week 48 Results
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