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.
FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
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