Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
Food and Drug Administration - June 15, 2005
Richard Klein
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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SOURCE: Food and Drug Administration (FDA).
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