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FDA approves new dosage strength of HIV drug

The US Food and Drug Administration (FDA) has approved new dosage strength of 200mg formulation of Intelence (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adults with resistance to an NNRTI and other antiretroviral (ARV) agents.

The recommended oral dose of Intelence tablets is 200 mg (one 200mg tablet or two 100mg tablets) taken twice daily after a meal.

This new 200mg product formulation is expected to launch in the US later this month, while the 100 mg tablet will remain available.

Intelence received FDA approval November 2009, and is currently marketed in the US by Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, LP.