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Generic efavirenz approved for PEPFAR use but 4 African countries reject US drug standard
Keith Alcorn, Tuesday, June 28, 2005
The United States Food and Drug Administration (FDA) announced on Friday that it had granted tentative approval for efavirenz tablets manufactured by Aurobindo Pharma Ltd of Hyderabad, India. This product is the first tentatively approved generic version of efavirenz.

Generic efavirenz will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).

However it has emerged that four African countries participating in PEPFAR have now told South Africa’s Aspen Pharma that even though antiretrovirals manufactured by the company have received tentative approval from the US FDA for PEPFAR purchase, the company will still have to obtain prequalification from the World Health Organization’s own registration programme. The Ugandan National Drug Authority has also told Aspen that its products must undergo national regulatory review in Uganda before they can be imported for use in PEPFAR-funded treatment programmes.

An Aspen spokesman told The Boston Globe last week that it expects the requirement for additional review will delay access to its products in the four countries – Uganda, Tanzania, Ethiopia and Nigeria – by nine to twelve months. However, spokesmen for the Ugandan and Nigerian regulatory agencies estimate that it will take only one to four months to process the applications, and said that they stood by the WHO prequalification process.