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FDA approves new drugs for pediatric patients
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The FDA recently approved a new drug for use in children and expanded the indications of two previously approved drugs.
The only varicella-zoster immune globulin preparation approved for use in the United States can now be given as post-exposure prophylaxis up to 10 days after disease exposure, according to the CDC.
Varicella-zoster immune globulin (VariZIG, Cangene Corp.) is a purified immune globulin preparation made from human plasma containing high levels of antivaricella-zoster virus antibodies (immunoglobulin G).
VariZIG is the only varicella-zoster immune globulin preparation available in the United States for post-exposure prophylaxis of varicella in patients at high risk for severe disease who lack evidence of immunity to varicella and are ineligible for varicella vaccine. VariZIG should be administered as soon as possible after exposure, according to a recent Morbidity and Mortality Weekly Report.
The FDA also expanded the indication for etravirine (Intelence, Tibotec Pharmaceuticals) to include the treatment of HIV-1 in patients aged at least 6 years in combination with other antiretroviral drugs. Etravirine was approved in January 2008 for the treatment of adults with resistance to non-nucleoside reverse transcriptase inhibitors and other antiretroviral treatments.
The FDA approved a new nasal aerosolized corticosteroid for the treatment of seasonal and perennial allergies in patients aged 12 years and older. The product is expected to be available this month, according to a press release from the manufacturer.
QNASL (Teva Pharmaceutical Industries) will be the first marketed non-aqueous nasal aerosol to be delivered once daily through a pressurized, hydrofluoroalkane-propelled non-aqueous aerosol that offers a built-in dose counter.
For more information, visit the FDA site.