FDA approves local manufacture of generics for export to Africa

Manufacture of a generic antiretroviral drug combination that was recently approved by the US Food and Drug Administration (FDA) could begin as early as April, local pharmaceutical company Aspen Pharmacare said this week.

According to KaiserNetwork news service, Aspen Pharmacare spokesman Stavros Nicolao said the first shipments of the medication were likely to be dispatched in April, depending on how quickly it could be registered in the 12 African countries benefiting from the President's Emergency Plan for AIDS Relief (PEPFAR).

Earlier this week the FDA announced that it had approved a generic version of the treatment made by Aspen Pharmacare, allowing the 12 countries to buy cheaper combination drugs made by foreign companies, rather than more expensive brand-name products from the US.

Nicolao was reported as saying that the South African company could begin production of the drugs six to eight weeks after it received orders from treatment groups. The combination will also be sold to countries receiving funds from the Global Fund to Fight AIDS, Tuberculosis and Malaria.