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On October 18, 2010, FDA granted tentative approval to fixed dose combination lamivudine/zidovudine tablets, 150mg/300mg, indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. The product is manufactured by Strides Arcolab Limited of Bangalore, India. The application was reviewed under expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR).
Combination products such as this one can decrease pill burden and may result in improved dosing compliance for HIV infected individuals.
"Tentative approval" means that FDA has concluded that a drug product meets all required quality, safety and efficacy standards, but is not presently eligible for final approval for marketing in the U.S. because of existing patents and/or exclusivity rights. However, tentative approval does make the product eligible for purchase and use outside the United States under PEPFAR.
As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility, and of the facilities performing the bioequivalence studies, to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application prior to granting approval or tentative approval to these applications.
This is a generic formulation of Combivir Tablets, 150 mg/300 mg, a product of VIIV HealthcareC ompany, which is subject to patent protection in the United States.
A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA website.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
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