Janssen Submits NDA for a Fixed-Dose Combination of Darunavir with Cobicistat

Janssen Research & Development, LLC , today announced it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for a once-daily fixed-dose antiretroviral combination tablet containing darunavir, a protease inhibitor developed by Janssen R&D Ireland and marketed as PrezistaA in the U.S., with cobicistat, an ... (more)

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