WHO removes two generic anti-HIV drugs from its approved list
June 17 2004 12:00 AM ET
The World Health Organization on Tuesday announced that it has removed two generic anti-HIV drugs made by Indian drug firm Cipla from its list of approved HIV treatments, The New York Times reports. Cipla's versions of lamivudine, sold in the United States as the brand-name drug Epivir, and zidovudine, sold as Retrovir, were removed from the approved list because of problems detected during a routine inspection of a laboratory Cipla hired to conduct bioavailability studies of the generic medications, says Lembit Rago, WHO's coordinator for quality assurance and safety of medicines. The inspection found the company's records didn't meet industry standards. There was no evidence cited that the drugs were not as effective as their brand-name equivalents, only that the documentation was inadequate. Cipla chairman Yusef Hamied says the company is taking steps to rectify the problem and insists that the generic anti-HIV drugs made by the drug firm are safe and effective. The company expects to have the medications relisted on the WHO approval list within a few weeks.
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