J&J: applies to FDA for expanded indication for Prezcobix
A parallel line extension application has also been submitted to the European Medicines Agency (EMA) for extended pediatric use in Europe, where the product is marketed under the name Rezolsta.
The laboratory reports that the new coformulated tablet (darunavir 675 mg/cobicistat 150 mg) has been developed to facilitate administration to young children. The new pediatric tablets are scored to facilitate swallowing.
If approved, this drug could provide healthcare providers with a new treatment option that ensures appropriate weight-based dosing to better meet the needs of young people living with HIV', said Penny Heaton, M.D., Global Director of Therapeutics, Infectious Diseases & Vaccines and Global Public Health R&D at Johnson & Johnson.
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