The US FDA has given tentative approval for a co-package of three antiretroviral drugs used together to initiate treatment against HIV/AIDS, which is manufactured by Aurobindo Pharma Ltd. The regimen, consisting of lamivudine/zidovudine fixed dose combination tablets and efavirenz tablets, is for the treatment of HIV-1 infection in adults. This is the first co-package of these products that has met the clinical safety and efficacy and the manufacturing quality standards of the FDA.
"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," Murray M. Lumpkin, FDA Deputy Commissioner for International and Special Programs said adding, "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."
Having received FDA's tentative approval, the product will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).
FDA granted tentative approval for the generic formulation of efavirenz on June 24, 2005, and for the fixed dose combination of lamivudine and zidovudine on July 7, 2005, both manufactured by Aurobindo Pharma LTD. Aurobindo Pharma's lamivudine/zidovudine fixed dose combination tablets are a version of the already FDA approved Combivir tablets manufactured by GlaxoSmithKline, and the efavirenz tablets are a version of Sustiva tablets manufactured by Bristol Myers-Squibb.