Janssen files darunavir/cobicistat for HIV with the FDA
Janssen R&D has submitted a New Drug Application to the FDA seeking approval for a once-daily fixed-dose antiretroviral combination tablet containing (Prezista) darunavir with cobicistat, developed by Gilead Sciences, use in combination with other Human Immunodeficiency Virus (HIV-1) medicines.
If approved, the fixed-dose combination tablet will be marketed under a new brand name and will, for the first time, offer an additional therapeutic option that eliminates the need to take a boosting agent in a separate tablet with once-daily darunavir. The combination was filed with the EU in October 2013.
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