FDAnews Drug Daily Bulletin

WORLD HEALTH ORGANIZATION PREQUALIFIES RANBAXY'S ANTIRETROVIRALS

Aug. 23, 2005
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The World Health Organization has placed Ranbaxy's seven antiretroviral drugs on a list of medicines prequalified for use in developing countries. The WHO prequalifies drugs that meet WHO safety and effectiveness standards.

The approved products include three fixed-dose combinations (FDCs) of lamivudine, nevirapine and stavudine; two lamivudine/stavudine tablets; a lamivudine/zidovudine tablet; a lamivudine tablet; and a zidovudine tablet, Ranbaxy said recently.

Ranbaxy voluntarily withdrew its antiretroviral FDCs from the WHO's prequalified drug list in November 2004 after it found documentation discrepancies regarding the products' bioequivalence with brand name counterparts.

The Indian drug firm conducted new clinical trials for the drugs before resubmitting the drugs for prequalification. This followed an August 2004 withdrawal by the WHO of three other Ranbaxy antiretrovirals, after the WHO found documentation discrepancies between the original results of bioequivalence studies by contract research organizations (CROs) and the results presented to the WHO.

The WHO prequalified a number of drugs in December 2003 as part of its plan to treat 3 million people with AIDS in developing countries by 2005.