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FDA Grants Accelerated Review Of Microbicide Developed By Australian Pharmaceutical Company
FDA on Tuesday granted an accelerated review for a microbicide gel developed by Australian pharmaceutical company Starpharma, The Australian reports (Ooi, The Australian, 1/10). The fast-track status means the agency will take half the standard time -- about six months -- to review the product, called VivaGel. The agency also will be more involved in further human trials of the gel (Greenblat, Australian Financial Review, 1/10). Microbicides include a range of products -- such as gels, films, sponges and other products -- that could help prevent the sexual transmission of HIV and other sexually transmitted diseases in women (Kaiser Daily HIV/AIDS Report, 11/1/05). VivaGel did not cause any harmful side effects in trials of 35 women in Australia and also was effective in preventing the spread of genital herpes. Trials including 100 women are planned to begin later this year, and VivaGel is likely to be ready for commercialization in 2008, according to Starpharma Chief Operating Officer Jackie Fairley (Australian Financial Review, 1/10).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
FDA Granturi acceleratã de examinare Microbicide dezvoltat de cãtre compania farmaceuticã australian - FDA Grants Accelerated Review Of Microbicide Developed By Australian Pharmaceutical Company - articole medicale engleza - startsanatate
