The United States' Food and Drug Administration this week granted tentative approval for a co-packaged antiretroviral drug regimen, consisting of lamivudine/zidovudine (AZT/3TC) fixed dose combination tablets and efavirenz tablets, for the treatment of HIV-1 infection in adults. It is manufactured by Aurobindo Pharma Ltd., Hyderabad, India.
Co-packaging of antiretroviral drugs which cannot be formulated into the same tablet should improve adherence by making clear to patients which doses of drugs should be taken at what times of day. AZT and 3TC fixed dose tablets are taken twice a day and efavirenz tablets are taken once a day.
FDA granted tentative approval for the generic formulation of efavirenz on June 24, 2005, and for the 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.
A Tentative Approval means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, though it may not yet be marketed in the United States due to existing patents and/or exclusivity rights. Tentative approval, however, does make the product eligible for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR) program.