HIV-AIDS drug gains tentative FDA approval

WASHINGTON, Oct. 29 (UPI) -- The U.S. Food and Drug Administration has tentatively approved the 75th anti-retroviral generic drug of the president's emergency plan for AIDS relief.

Marketed by Macleods Pharmaceuticals Ltd. of Kachigam, Daman, in India, the FDA said the drug -- generic lamivudine -- is a nucleoside analog reverse-transcriptase inhibitor that blocks an enzyme called reverse transcriptase that's important to human immunodeficiency virus production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop fewer opportunistic infections, the FDA said.

However, the FDA said tentative approval means that although existing patents and/or marketing exclusivity prevent the approval of the product in the United States at this time, the product meets all of the FDA's normal requirements for manufacturing quality, clinical safety and efficacy.