FDA approves generic AIDS drug combo

NEW YORK — The Food and Drug Administration on Tuesday tentatively approved a generic and less costly version of a widely used AIDS drug combination, an action that is expected to expand AIDS treatment in the developing world.

The approval came as part of an expedited FDA review process that was started last year after the Bush administration was criticized for refusing to purchase drugs that hadn't been reviewed by the FDA. AIDS activists contended the administration was trying to bolster the sales of U.S. drug makers at the expense of AIDS patients in the developing world.

The FDA backing means the product made by Aspen Pharmacare, South Africa's largest drug maker, which combines two pills in a package, can now be purchased by relief organizations funded by President Bush's $15 billion emergency AIDS relief plan. The five-year program was approved by Congress in 2003, but a policy decision was made to not pay for drugs unless they had been approved by the FDA.

It marks the first time the FDA has approved a generic AIDS product made by a foreign drug company. The FDA approved a generic drug made by Barr Laboratories in December, but Tuesday's announcement is considered a major advancement because the Aspen drug combination is so widely used as a first-line therapy.

Aspen's package includes one pill that is the generic equivalent of Combivir made by GlaxoSmithKline PLC of the United Kingdom and contains two drugs, lamivudine and zidovudine. The second pill is nevirapine, a generic version of Viramune, made by Boehringer Ingelheim GmbH of Germany.

The two drug makers earlier licensed Aspen to produce the drugs.

"For people in Africa and beyond this can be a turning point in providing low cost, safe and effective drugs to people who otherwise would have died," said Mark Isaac, vice president of the Elizabeth Glaser Pediatric AIDS Foundation, which receives funding from the president's plan.

Aspen officials could not be reached for comment. Based on the price of other generic drugs, Isaac estimated that the cost of the combination treatment could be about $20 to $30 per person per month. His foundation now pays $55 per person per month for the same brand-name drugs.

The approval is considered tentative because Aspen won't be able to sell its regimen in the United States where its components remain under patent protection, said Dr. Murray Lumpkin, the FDA's acting deputy commissioner for international and special projects.