AUROBINDO WINS APPROVAL FOR GENERIC ARV IN SOUTH AFRICA

Aurobindo Pharma, based in India, has received marketing authorization approval from Medicines Control Council (MCC) of South Africa for generic stavudine tablets in 30- and 40-mg strengths.

Stavudine is a synthetic thymidine nucleoside analogue. The drug's international brand name is Zerit, which is marketed by Bristol-Myers Squibb. Stavudine is used in combination with other antiretrovirals (ARVs) for treating HIV.

The South African market is highly regulated and very important in its geographical sphere, according to Aurobindo. The company said it has now won approval for five of its generic ARVs in the country.

In September the MCC approved the company's generic lamivudine 150-mg tablets, zidovudine 300-mg tablets, nevirapine 200-mg tablets and tablets containing 150 mg of lamivudine plus 300 mg of zidovudine. South African regulators also inspected the Aurobindo's facility in Hyderabad, India, and found it to be in compliance with current good manufacturing practices.