Generic Drug Maker Ranbaxy To Resubmit Three AIDS Drugs Dropped From WHO Treatment List
Indian generic drug manufacturer Ranbaxy plans to resubmit to the World Health Organization by the end of the year three generic antiretroviral drugs that the organization removed from its list of prequalified HIV treatments, according to Ranbaxy CEO Brian Tempest, Reuters reports (Reuters, 10/18). WHO in August removed the medications -- including a fixed-dose combination of lamivudine, stavudine and nevirapine in two strengths and a lamivudine, zidovudine combination pill -- after inspecting the contract research organization that conducted tests to determine whether the medications were bioequivalent to the patented versions. WHO decided to remove the drugs after determining that the testing lab failed to meet international standards of clinical and laboratory practices, marking the second time this year that the organization has removed generic AIDS medications from its list of prequalified drugs. WHO in June removed Indian generic drug manufacturer Cipla's versions of lamivudine and zidovudine from its approved HIV treatment list because of problems detected during a similar inspection of an independent laboratory that Cipla had hired to conduct its bioequivalence studies (Kaiser Daily HIV/AIDS Report, 8/6).
Ranbaxy also plans to submit the drugs for FDA approval by the end of the year in an effort to include the drugs in the President's Emergency Plan for AIDS Relief, according to Reuters (Reuters, 10/18). PEPFAR is a five-year, $15 billion program that directs funding to 12 African nations -- Botswana, Ethiopia, Cote d'Ivoire, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda and Zambia -- as well as Haiti, Guyana and Vietnam (Kaiser Daily HIV/AIDS Report, 10/14). PEPFAR so far has "refused" to buy generic drugs approved by WHO because U.S. officials say that FDA should be involved in determining medicines' quality, Reuters reports. However, if Ranbaxy gains FDA approval for its generic antiretrovirals, they could be distributed in countries included under PEPFAR. The medications would not be sold in the United States because of patent protection laws. "What happened was unfortunate and we are re-doing all the bioequivalence studies around the world, and we will be filing with the WHO and [FDA] by the end of the year," Tempest said (Reuters, 10/18).