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On December 22, 2010, the Food and Drug Administration approved a new 200 mg Intelence (etravirine) tablet. Intelence was originally approved in 2008, in only a 100 mg tablet formulation. The new 200 mg dosage form can help reduce pill burden for patients taking Intelence.
The dosage Dosage and Administration section was changed to state: 200 mg (one 200 mg or two 100 mg tablets) taken twice daily following a meal.
Intelence is a Nonnucleoside Reverse Transcriptase Inhibitors (NNRTI), made by Tibotec Therapeutics.
The revised product label, reflecting the 200 mg tablet approval can be found at http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s007lbl.pdf
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
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