Aurobindo AIDS drug gets US FDA approval

The US Food and Drug Administration has given tentative approval to a drug developed by India's Aurobindo Pharma that checks the reproduction of AIDS virus.

With the approval, the drug, Zidovudine, a generic liquid version of a child-friendly oral solution, could now be used overseas under the US programme to fight the deadly virus.

Zidovudine, manufactured by Aurobindo Pharma Ltd, Hyderabad, is the first tentatively approved generic versionof Zidovudine oral solution, manufactured by Glaxosmithkline.

Glaxo sells the drug, that checks the growth of AIDS virus, under the brand Retrovir or atz. Zidovudine is to be used with other antiretroviral agents for the treatment of HIV-1 infection.

The US FDA has already granted a tentative approval to a generic combination drug product manufactured by the company consisting of Lamivudine 150 mg and Zidovudine 300 mg.

" FDA is delighted to help to ensure that AIDS products available to children through the President's emergency programme are safe and effective," deputy commissioner for international and special programmes Dr Murray M Lumpkin said in the FDA website.

The emergency plan for AIDS, launched by President George W Bush in 2003 for five years, is currently providing a US $15 billion aid to fight the disease in the hardest-hit countries, the website said.

The plan is designed to prevent new HIV infections and treat the individuals and children affected with the virus, it said.

FDA's tentative approval means the drug meets safety, efficacy and quality standards set by the drug body. The generic drug, however, will not be available in the United States because of the strict patent regime.