FDA Approves 50th, 51st Anti-Retroviral Drugs
FDA granted tentative approval for nevirapine tablets, indicated for use with other antiretroviral agents for the treatment of HIV-1 infection, and for the pediatric triple fixed dose combination tablet of lamivudine, stavudine and nevirapine -- the first fixed dose anti-HIV product designed to treat children under the age of 12 years. These two drugs mark the 50th and 51st AIDS drugs approved or tentatively approved for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).
The fixed dose combination comprises a complete HIV regimen that is taken twice daily and can be used once patients have tolerated 14 days of lead-in treatment with nevirapine taken once daily. The tablet combination can also be dissolved in water for children who cannot swallow tablets. The fact that all three drugs are combined in one tablet and that this tablet can be stored, distributed, and administered easily to children is a significant advance in the treatment of children infected with HIV in PEPFAR countries.
"The 50th and 51st approvals by the FDA of essential anti-HIV products under the President's Emergency Plan for AIDS Relief bolsters the commitment made by President Bush to ensure the rapid delivery of unprecedented amounts of safe, effective, and quality drugs, at a lower cost, to help those most in need," said HHS Secretary Mike Leavitt in marking the milestone.
Today's approvals under the PEPFAR process are part of the President's five-year, $15 billion effort to fight the HIV/AIDS pandemic around the world