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Medical News

Generic Drug Maker Receives FDA, PEPFAR Approval for Drug to Treat HIV-Positive Children

March 14, 2011

The generic drug maker Mylan Inc. on Thursday announced it has received final approval from the FDA under PEPFAR for a new formulation of the antiretroviral drug zidovudine that is specifically meant to treat children with HIV/AIDS, RTT News reports (3/10). The drug is a "first-of-its-kind" water-dispersible tablet that can also be used to prevent mother-to-child transmission of HIV, the Pittsburgh Business Times reports (Mamula, 3/10). "It will be made available for purchase outside the U.S. in certain developing countries," the Associated Press/Canadian Business Online reports (3/10). "The FDA's approval under PEPFAR means that Matrix's product meets all of the agency's manufacturing quality, safety and efficacy standards. The water-dispersible tablet is unique because it can be dispersed in water for all patients, adults or children, who are unable to swallow tablets," according to a Mylan press release (3/10).

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This information was reprinted from kff.org with permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives, and sign up for email delivery. © Henry J. Kaiser Family Foundation. All rights reserved.



  
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily Global Health Policy Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.
 
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