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U.S. Department of Health and Human Services

For Consumers

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Tentative approval of generic lamivudine

On January 29, 2008, FDA granted tentative approval for a generic version of lamivudine tablets, 150 mg and 300 mg, manufactured by Hetero Drugs Limited,  Hyderabad, India, for use in combination with other antiretrovirals in the treatment of HIV infection.

"Tentative Approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, even though it is not yet eligible to be marketed in the U.S. because of existing patents and/or exclusivity rights. However, this tentative approval does make the product eligible for consideration for purchase under the PEPFAR program.

This is a generic version of Epivir, manufactured by GlaxoSmithKline, which is subject to existing patent protection.

Effective patent dates can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"

As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to these applications to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration