ROCKVILLE, Md., June 30 (UPI) -- The U.S. Food and Drug Administration said Friday it has tentatively cleared a new three-way drug cocktail to treat HIV/AIDS.
The agency said it has approved a first-of-its-kind, three-ingredient fixed-dose tablet -- made by Indian firm Aurobindo -- as a stand-alone anti-retroviral treatment in adults.
The pill (lamivudine-zidovudine-nevirapine) contains the active ingredients in the brand HIV drugs Epivir, Retrovir and Viramune.
The FDA granted tentative approval because the sponsor has met all of the agency's safety and efficacy requirements, but there remain outstanding patent and/or market-exclusivity issues that preclude the drug being sold on the U.S. market immediately.
However, the FDA said the AIDS cocktail will be available for purchase and distribution in 15 other countries under the president's Emergency Plan for AIDS Relief.
"Today's approval marks a significant step forward in our commitment to clearing the way to quickly deliver quality, life-saving HIV/AIDS drugs to people who desperately need them in developing countries," Secretary of Health and Human Services Michael Leavitt said in a statement Friday.
"This new option, a fixed dose combination tablet containing lamivudine, zidovudine, and nevirapine, simplifies the treatment of HIV-1, which is a stumbling block for many individuals who find it difficult to maintain a regimen requiring the use of several drugs."
