Intelence Receives New FDA Approval

FDA approves new 200 mg tablet for HIV/AIDS medication

/ Author:  / Reviewed by: Joseph V. Madia, MD

Intelence, a medication taken by HIV/AIDS patients, has just been approved for a new 200 mg tablet, a move that will help lessen the number of pills which need to be taken daily.

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