16 June, 2005: AIDS drug lamivudine, being manufactured by Aurobindo Pharma, has got a tentaive US Food and Drug Administration (USFDA) apprval. The approval allows Aurobindo Pharma to sell its lamivudine tablets as part of US President's Emergency Plan for AIDS Relief programme.
However, the approval does not permit the company to market the drug in US, other than through the HIV/AIDS Relief programme, the USFDA said in a statement.
"This is an indication of the Department of Health and Human Services' and 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 M Lumpkin, MD, Acting Deputy Commissioner for International and Special Programmes.
Lamivudine, a Nucleoside Reverse Transcriptase Inhibitor (NRTI), stops HIV from infecting uninfected cells in the body. It also helps block the spread of hepatitis B. The antiretroviral Lamivudine drug is used in combination with other antiretroviral agents for the treatment of HIV-1/AIDS infection.
This was the second application for Lamivudine tablets for which FDA has granted tentative approval.
The agency's tentative approval means that although existing patents and or exclusivity prevent marketing of the product, it meets FDA's quality, safety and efficacy standards.
The Emergency Plan for AIDS Relief, which S President george Bush first announced in his 2003 State of the Union Address, is currently providing $15 billion to fight the HIV/AIDS pandemic over the five years. It also aims to pay for treatment for 2 million AIDS sufferers and provide care for 10 million others in 15 target countries, mostly in Africa.