FDA actions in brief, March 2008

A summary of drugs and indications recently approved by FDA: Intelence, Alvesco Inhalation Aerosol, Moxatag, Humira, Asmanex, Tekturna HCT, Herceptin

Etravirine (Intelence, Tibotec) was approved for use with other antiretroviral agents for the treatment of HIV-1 infection in antiretroviral treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.

Ciclesonide (Alvesco Inhalation Aerosol, Nycomed) was approved for the maintenance and prophylactic treatment of asthma in adult and adolescent patients aged ≥12 years.

Once-daily amoxicillin extended-release tablets (Moxatag, MiddleBrook) were approved for the treatment of adults and pediatric patients aged ≥12 years with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes.

Mometasone inhalation powder (Asmanex Twisthaler, Schering-Plough) was approved for the maintenance treatment of asthma as a preventative therapy in patients aged 4 to 11 years.

Aliskiren/hydrochlorothiazide (Tekturna HCT, Novartis) was approved for the treatment of hypertension.

Trastuzumab (Herceptin, Genentech) was approved as adjuvant monotherapy for the treatment of early-stage HER2-positive breast cancer.