The FDA has approved a label
update to include a 200 mg 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 200 mg tablet or two 100 mg tablets) taken
twice daily following a meal. The new 200 mg product formulation is expected to
launch in the U.S.
later this month, and the 100 mg tablet will remain available. Patients who are
unable to swallow INTELENCE tablets whole may disperse the tablets in a glass
of water.
The FDA granted accelerated
approval to INTELENCE in January 2008, and it has since been approved in more
than 65 countries. INTELENCE received traditional FDA approval in November
2009, based on 48-week data from the DUET-1 and DUET-2 studies, and is currently
marketed in the U.S.
by Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P.
