The regimen consists of lamivudine/zidovudine fixed dose combination tablets and efavirenz tablets. They are used to combat HIV-1 infection in adults.
This is the first co-package of these products that has met the clinical safety and the manufacturing quality standards of the FDA.
Murray M. Lumpkin, M.D., FDA Deputy Commissioner for International and Special Programs, says, "The co-packaging of these drugs should make distribution of the drugs easier in many situations and make it easier for patients to take the right drugs in the right amount at the right time."
He adds, "This should be particularly helpful in many of the areas of the world being especially targeted by the President's Plan, where the co-package can offer a full HIV treatment regimen for an HIV infected individual initiating therapy."
The agency's tentative approval means that existing patents and/or exclusivity prevent approval of this product in the United States. Even so, the FDA finds the drugs meet quality, clinical safety and efficacy standards required for marketing in the United States.
The product will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).
