The United States Food and Drug Administration (FDA) announced yesterday that it has granted a tentative approval for generic lamivudine tablets, 150 mg and 300 mg, manufactured by Aurobindo Pharma Ltd., Hyderabad, India.
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, 150mg.