First Indian generic ARV given US FDA approval

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The Indian pharmaceutical company Ranbaxy has announced that it has received `tentative approval` of its version of lamivudine (3TC) from the US Food and Drug Administration. The product is the first antiretroviral from an Indian manufacturer to be approved by the US drug regulator for purchase by the President’s Emergency Plan for AIDS Relief (PEPFAR).

`Tentative approval` from the FDA means that the product is considered bioequivalent (producing the same drug levels) to the originator product, in this case Epivir, manufactured by Glaxo SmithKline, and can be used in PEPFAR treatment programmes, but not sold in the United States while the originator product is still under patent.

The FDA’s expedited review procedure for antiretrovirals was introduced in 2004 in order to allow the US government to purchase cheaper versions of antiretrovirals. The US government has refused to purchase drugs that are copies of patented products without stringent bioequivalence testing.

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.

A number of antiretrovirals manufactured by Indian companies have been suspended or withdrawn from the World Health Organization’s prequalification list, due to problems with the documentation of bioequivalence testing. Critics of generic products have used these withdrawals to argue that the WHO prequalification process is flawed, and that Indian-manufactured products are potentially inferior or even harmful. It is, however, likely to prove more difficult to sustain such arguments as more Indian products are approved by the US Food and Drug Administration.