New & experimental HIV treatments

US FDA approves coblistered triple combination for developing country use

Keith Alcorn
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The US Food and Drug Administration announced yesterday that it has approved a coblistered triple combination of AZT, 3TC and nevirapine manufactured by the South African company Aspen Pharmacare.

The generic triple combination is composed of fixed dose tablets containing AZT (zidovudine) and 3TC (lamivudine), co-packaged with nevirapine tablets. It is the first generic fixed dose antiretroviral product to be approved by the FDA under new regulations introduced last May.

The product has received tentative approval, which means that it can be purchased by the President’s Emergency Plan for AIDS Relief (PEPFAR) for use in developing countries, but may not be marketed in the United States.

Glossary

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.

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.

Aspen has not yet announced a price for the product, which contains drugs manufactured under voluntary licenses granted by GlaxoSmithKLine (Combivir) and Boehringer Ingelheim (Viramune).

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