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FDA Tentatively Approves Generic Zidovudine Oral Solution

SEPTEMBER 8, 2005 -- ROCKVILLE, MD -- The U.S. Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS) today announced the tentative approval of zidovudine oral solution, a generic version of a child-friendly oral solution to help keep AIDS virus from reproducing.

Zidovudine, manufactured by Aurobindo Pharma LTD. Hyderabad, India, is the first tentatively approved generic version of Retrovir brand of the zidovudine oral solution (manufactured by GlaxoSmithKline). This dosage form of the drug is the first child-friendly oral solution available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).

"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 the HIV/AIDS products available to children through the President's Emergency Program are safe and effective," said Dr. Murray M. Lumpkin, Deputy Commissioner for International and Special Programs.

The Emergency Plan for AIDS Relief, which President Bush first announced in his 2003 State of the Union Address, is currently providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest-hit countries. The President's Emergency Plan is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children. It targets three specific areas related to HIV/AIDS:

- Prevention of HIV transmission;
- Treatment of AIDS and associated conditions;
- Care, including palliative care for HIV infected-individuals, and care for orphans and vulnerable children.

Zidovudine is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This anti-retroviral drug is intended to be used with other antiretroviral agents for the treatment of HIV-1 infection. This product contains 50 mg/5mL of zidovudine in an oral solution.

The agency’s tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the United States , it meets all of HHS and FDA's quality, safety and efficacy standards for U.S. marketing. More information on HIV and AIDS is available online at FDA's website:

Source: The Food and Drug Administration

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