US approves fixed dose generic product for PEPFAR use

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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.

Glossary

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

fixed-dose combination (FDC)

Two or more drugs contained in a single dosage form, such as a capsule or tablet. By reducing the number of pills a person must take each day, fixed-dose combination drugs may help improve adherence.

nucleoside

A precursor to a building block of DNA or RNA. Nucleosides must be chemically changed into nucleotides before they can be used to make DNA or RNA. 

combination therapy

A therapy composed of several drugs available either as separate tablets, or as fixed-dose combination (FDC).

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.