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FDA Adds Children to HIV Drug Indication
WASHINGTON -- The FDA has expanded the indication for etravirine (Intelence) to include treatment of HIV-1 in pediatric patients ages 6 and older in combination with other anti-retroviral medication.
The expansion means that the drug is now also indicated for pediatric patients who are experiencing virologic failure with HIV-1 strains resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) and other anti-retroviral medications, a statement from manufacturer Janssen Therapeutics said.
The approval adds a new, 25-mg dose of the drug, which allows weight-based treatment for pediatric patients.
Etravirine was approved in January 2008 as a treatment for adults with resistance to NNRTIs and other anti-retroviral treatments.
Full story on HIV drug and children at Med Page Today