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FDA approves first generic AIDS drugs

The U.S. Food and Drug Administration (FDA) has today awarded its first ever seal of approval to antiretroviral AIDS drugs made by a generics manufacturer.

Aspen Pharmacare, a South African pharmaceutical company, has been making generic antiretroviral drugs for several years with approval from the World Health Organisation, and permission from all the pharmaceutical companies that currently hold the patents to the drugs. However, any country wishing to buy these cheaper treatments with money from the American PEPFAR scheme (the President’s Emergency Fund For AIDS Relief), have until now been unable to do so, as the plan’s guidelines stipulate that only FDA approved drugs can be bought with PEPFAR money.

The approval will have important implications for many organisations and individuals around the world, as at approximately half the price of brand-named drugs, generics can effectively be used to treat twice as many people.

The two drugs approved by the FDA are copies of Combivir (which is made by Glaxo Smith Kline and contains a combination of AZT and lamivudine) and Viramune (made by Boehringer-Ingelheim and containing nevirapine). Both pills must be taken together daily to be effective. Some companies in India have gone so far as to combine these drugs into one tablet, which makes HIV treatment even more straightforward. The FDA has yet to officially approve these drugs, but is hoped that applications will be processed soon and fast-track approval will be granted within the next few months.

AVERT.org has more information about PEPFAR and Generic drugs