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Today, June 15, 2005, FDA granted a tentative approval for generic
lamivudine tablets, 150 mg and 300 mg, manufactured by Aurobindo Pharma
Ltd., Hyderabad, India. Lamivudine tablets are indicated for use in
combination with other antiretroviral agents for the treatment of HIV-l
infection.

A Tentative Approval means that FDA has concluded that a drug product has
met all of the required quality, safety and efficacy standards, even though
it may not yet be marketed in the U.S. due to existing patents and/or
exclusivity. It does, however, make the product eligible for use under the
President's Emergency Plan for AIDS Relief (PEPFAR) program outside the
United States.

This is the second application for lamivudine tablets for which FDA granted
tentative approval under the PEPFAR expedited review program. On May 27,
2005, FDA granted tentative approval to Ranbaxy Laboratories Limited, for
lamivudine tablets, 150 mg.


Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration

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