Maryna Auramchuk/iStock via Getty Images Johnson & Johnson ( NYSE: JNJ ) has submitted a supplemental New Drug Application to the U.S. FDA to expand the indication for the HIV medicine Prezcobix (darunavir/cobicistat) to children as young as six weighing at least 25 kilograms.
If approved, the drug would be produced with a weight-adjusted pediatric dose. The application is supported by data from two trials. Johnson & Johnson ( JNJ ) also submitted a similar application for the same patient expansion to the European Medicines Agency.
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