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Etravirine Label Updated With 48-Week Data
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"On November 24, 2009, FDA approved revisions to the INTELENCE (etravirine) labeling to include updated results through 48 weeks of dosing for the two Phase 3 trials TMC125-C206 and TMC125-C216 in treatment-experienced patients. This constitutes the required confirmatory data for Traditional approval....
"Co-administration of INTELENCE™ with drugs that are substrates of CYP3A, CYP2C9, and/or CYP2C19 or are transported by P-glycoprotein may alter the therapeutic effect or adverse reaction profile of the co-administered drug(s)."
More information is available:
- Read the FDA press release
- Read the ClinicalTrials.gov trial summary for TMC125-C206
- Read the ClinicalTrials.gov trial summary for TMC125-C216
- Read the AIDS info etravirine (Intelence) fact sheet
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