UN health agency relists several generic HIVAIDS drugs adds others

Four of the medicines re-listed were withdrawn by the manufacturer, Ranbaxy Laboratories Ltd of India, in November, while the other three were de-listed by the UN World Health Organization (WHO) last August 2004.The medicines were de-listed because WHO inspections of independent laboratories used by the manufacturer to run bioequivalence studies revealed practices which did not conform to international standards required by the agency.Ranbaxy commissioned different laboratories to do new tests on the products’ bioequivalence with the originator medicines. Subsequently, WHO ran the full range of quality, safety and efficacy checks on the medicines as well as thorough inspections of the new laboratories and the products and laboratories were all found to be satisfactory. The three ARVs added are produced by Aurobindo Pharma Ltd., also of India. The addition of the 10 medicines will benefit existing AIDS programmes and procurement schemes, WHO said in a news release.It will reinforce efforts to scale up access to ARVs in high-burden countries by increasing the choice of quality products in nations which may have only limited capacity to control and monitor medicines. Currently, approximately 6.5 million people in low- and middle-income countries need ARV therapy.The 10 ARVS are: Ranbaxy products Lamivudine 150 mg tablet, Lamivudine/Stavudine 150 mg/40 mg tablet, Lamivudine/Stavudine 150 mg/30 mg tablet, Zidovudine 300 mg tablet, Lamivudine/Stavudine/Nevirapine 150mg/40mg/200mg tablets, Lamivudine/Stavudine/Nevirapine 150mg/30mg/200mg tablets, and Lamivudine/Zidovudine 150mg/300mg tablets; Aurobindo products Lamivudine 150mg tablets, Lamivudine 300mg tablets and Zidovudine 300mg tablets. read more

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