The US Food and Drug Administration has tentatively approved a generic version of an AIDS drug destined for use in poor countries, under US plans to speed up the approval of copycat versions of HIV/AIDS drugs and make them available at reduced prices to millions of people in the developing world [[18/05/04e]].
Specifically, Indian company, Aurobindo Pharma, has won the tentative green light for its version of lamivudine tablets. The FDA says that the drug will now “be available for consideration for purchase under the President’s Emergency Plan for AIDS Relief.” It is the second application for lamivudine tablets for which the FDA has granted tentative approval.
“This action today is yet another indication of the Department of Health and Human Services’ and the FDA’s deep commitment to the President’s Emergency Plan by helping to ensure that the products offered to patients under this plan are indeed safe, effective, quality medications,” said Murray Lumpkin, the FDA’s acting deputy commissioner for international and special programmes.
Lamivudine, which is marketed by GlaxoSmithKline under the brand name Epivir, belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors, which stop the HIV from infecting uninfected cells in the body.