FDA Grants Cipla Tentative Approval for Oral Version of Antiretroviral Drug Efavirenz

FDA Grants Cipla Tentative Approval for Oral Version of Antiretroviral Drug Efavirenz

[May 31, 2006]

Indian drug maker Cipla on Thursday received tentative FDA approval to produce an oral version of the antiretroviral drug efavirenz, Reuters Health reports (Reuters Health, 5/29). The tentative approval designation means the drug meets FDA safety and efficacy standards but cannot be sold in the U.S. because of existing patents or exclusivity agreements (Kaiser Daily HIV/AIDS Report, 1/5). In January, former President Clinton announced an agreement reached by the Clinton Foundation that will allow the sale of efavirenz produced by Indian companies Cipla, Ranbaxy Laboratories and Strides Arcolab, as well as South Africa's Aspen Pharmacare, to people in developing countries for no more than $240 per patient annually. In March, Merck announced that it is reducing the price of efavirenz in developing countries by 20% from 95 cents daily to 76 cents daily, making the new annual cost of the drug $277.40 for the 600 milligram formulation (Kaiser Daily HIV/AIDS Report, 3/7).