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Generic version of abacavir approved for use by PEPFAR programmes
Keith Alcorn, Tuesday, May 23, 2006
The US Food and Drug Administration (FDA) has announced tentative approval for a generic version of abacavir tablets (300 mg), manufactured in India by Aurobindo Pharma. Abacavir sulfate tablets are the first generic version of the already approved Ziagen, an anti-HIV medication manufactured by GlaxoSmithKline. Tentative approval makes this product available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).

The agency's tentative approval means that Aurobindo's product meets all of FDA's manufacturing quality and clinical safety and efficacy standards, but existing patents and/or exclusivity prevent its marketing in the United States at this time.

Earlier this year the Clinton Foundation announced that it had secured an agreement with the Indian generic manufacturer Cipla to offer a generic version of abacavir at a ceiling price of $440 a year. It is unclear whether Aurobindo will also participate in this agreement.

Abacavir is a nucleoside reverse transcriptase inhibitor (NRTI), and is a useful alternative to zidovudine (AZT) or stavudine (d4T), nucleoside analogues that may cause side effects such as anaemia and lactic acidosis respectively. However, even at a reduced price of $440 a year it is unlikely to be widely adopted as an alternative nucleoside analogue in developing countries.

Abacavir’s main use is likely to be in patients with tuberculosis who require immediate antiretroviral therapy alongside rifampicin, since it does not interact with rifampicin unlike the non-nucleoside nevirapine and the protease inhibitors.