FDA Tentatively Approves Generic AIDS Drug Cocktail

The FDA has granted its first tentative approval for an HIV drug regimen manufactured by a generic pharmaceutical company outside of the U.S., the agency said.

The co-packaged antiretroviral (ARV) drug regimen is manufactured by Aspen Pharmacare of South Africa, and is indicated for the treatment of HIV-1 infection in adults, the FDA said. The regimen includes co-packaged lamivudine/zidovudine fixed-dose combination tablets, as well as nevirapine tablets.

GlaxoSmithKline manufactures a brand version of the lamivudine/zidovudine combination tablets under the name Combivir. The nevirapine tablets are a generic version of Boehringer-Ingelheim Pharmaceuticals' Viramune tablets.

Aspen Pharmacare said the approval paves the way for it to access President Bush's Emergency Plan for AIDS Relief (PEPFAR). "This development represents a significant window of opportunity for Aspen in that it now has access to PEPFAR's $15 billion in funds to manufacture generic ARVs for specified developing countries," said Aspen Pharmacare Chief Executive Stephen Saad. "An additional advantage is that at present there are no generic pharmaceutical manufacturers globally other than Aspen that have voluntary licenses for the patents of the generic ARVs, have obtained FDA acceptance of a facility as a source of approved generic ARVs and have FDA approval of their generic ARVs."

Announced in President Bush's 2003 State of the Union Address, PEPFAR is a five-year, $15 billion plan, including nearly $10 billion in new money, to support global efforts combating AIDS in Africa and the Caribbean. The plan aims to provide AIDS drugs to 2 million HIV-infected patients.