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Monday, May 23, 2011
Tibotec Pharmaceuticals Inc.of Raritan, N.J., a unit of Centocor Ortho Biotech Inc., said the FDA approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in treatment-naïve patients. Edurant is a non-nucleoside reverse transcriptase inhibitor. The drug also is part of the single-tablet regimen combining it with Truvada (emtricitabine/tenofovir disoproxil fumarate) from Foster City, Calif.-based Gilead Sciences Inc. Dubbed "Btripla," the combo pill received a refuse-to-file letter for its new drug application in January, with requests for additional chemistry, manufacturing and controls information. Gilead resubmitted the application a few weeks later.

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