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The US Food and Drug Administration (FDA) has tentatively approved the first generic oral anti-AIDS medication for children.
Retrovir is the latest in a string of approvals for use in the US presidential plan to tackle HIV/AIDS in developing countries.
The drug is a generic version of Zidovudine, manufactured by GlaxoSmithKline and copied by India-based drugmaker Aurobindo Pharma.
Dr Murray Lumpkin, the FDA's deputy commissioner for international and special programmes, said in a statement, "Working together with colleagues in the Department of Health and Human Services, and the Office of the US Global AIDS Coordinator, FDA is delighted to help to ensure that anti-AIDS products available to children through the President's Emergency Programme are safe and effective."
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