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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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