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For Consumers

Tentative approval of generic abacavir/lamivudine/zidovudine fixed-dose combination tablet

On July 15, 2009, FDA granted tentative approval to a fixed-dose combination tablet containing abacavir sulfate, lamivudine and zidovudine Tablets,300 mg/150 mg/300 mg, manufactured by Matrix Laboratories Limited of Hyberdad, India, indcated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.  Fixed dose combination tablets significantly reduce pill burden and may help to improve adherence to drug regimens containing these products.

 

Tentative approval means that FDA has concluded that a drug product has met all of the required quality, safety and efficacy standards, but that it may not be marketed in the U.S. due to existing patents rights. However, tentative approval makes the product eligible to be considered for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR) program. Existing patent information is available in the FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

 

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 of 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.

 

A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan can be found on the FDA website.

 

The abacavir sulfate/lamivudine/zidovudine fixed dose combination tablets are a version of the FDA approved Trizivir Tablets, 300 mg/150 mg/300 mg, manufactured by GlaxoSmithKline.

 

Richard Klein
Office of Special Health Issues
Food and Drug Administration

 

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Page Last Updated: 08/20/2014
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