The US Food and Drug Administration today granted tentative approval to a fixed dose combination of zidovudine (AZT, ZDV) and lamivudine (3TC) manufactured by the Indian company Aurobindo. It is the second generic fixed dose antiretroviral product to be given the green light for use in programmes funded by the President’s Emergency Plan for AIDS Relief (PEPFAR).
The product is a version of Glaxo SmithKline’s Combivir and contains two of the drugs recommended by the World Health Organization (WHO) as a suitable nucleoside analogue backbone for triple combination therapy in resource-limited settings. A coblistered package of nevirapine plus AZT/3TC produced by Aspen Pharmacare of South Africa was approved earlier this year.
There is a widespread international consensus, shared by PEPFAR’s programme managers, that fixed dose combinations are essential for maintaining good adherence and simplifying drug supply in resource-limited settings. The US tentative approval system was established last year in order to allow PEPFAR to buy FDA approved products; although the generic drugs cannot be sold in the United States, they can now be purchased for use abroad with US government money as a result of FDA approval.
However, the international supply of fixed dose products remains limited due to lingering questions over the quality of some Indian products.
Last August the WHO announced that it was removing a number of fixed dose products from its list of preapproved products after doubts arose over the accuracy of some tests carried out during the development of a number of products manufactured by the Indian companies Cipla and Ranbaxy. The removal created supply problems for some treatment programmes, and the return of the products to the preapproval list awaits the submission of data from new studies by the manufacturers.