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HIV/AIDS Therapy

U.S. FDA tentatively approves a co-package of generic AIDS drugs

Published in AIDS Weekly, April 24th, 2006

The Food and Drug Administration (FDA) announced the tentative approval of a co-package of three antiretroviral drugs used together to initiate treatment against HIV/AIDS.

The regimen, consisting of lamivudine/zidovudine fixed dose combination tablets and efavirenz tablets, is for the treatment of HIV-1 infection in adults. It is manufactured by Aurobindo Pharma Ltd. of Hyderabad, India. This is the first co-package of these products that has met the clinical safety and efficacy and the manufacturing quality standards of the FDA.

"The co-packaging of these drugs should make distribution of the drugs easier in many situations and make it easier for...

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