FDA approves Aurobindo's generic abacavir sulphate

The US Food and Drug Administration says that it has tentatively approved Indian firm Aurobindo Pharma's generic abacvir sulphate tablets, marketed as the anti-HIV medication Ziagen by UK drug major GlaxoSmithKline. Abacavir is a non-nuceloside reverse transcription inhibitor which is used to prevent the virus from reproducing.

The tentative approval indicates that the product meets with the agency's manufacturing quality, clinical safety and efficacy standards, but that existing patents prevent the Indian firm from marketing the compound in the USA. The FDA added that the product could be sold outside the country and will now be available for consideration under the US President's Emergency Plan for AIDS relief.