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Tentative approval, fixed dose combination

Food and Drug Administration - September 14, 2006
Richard Klein & Kimberly Struble

The Food and Drug Administration (FDA), on September 13, 2006, granted tentative approval for a fixed dose tablet containing lamivudine/zidovudine 150 mg/300 mg manufactured by Cipla Limited of Mumbai, India. The tablets are indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

Tentative approval means that FDA has concluded that a drug product has met all of the required quality, safety and efficacy standards, though it may not be marketed in the U.S. due to existing patents and/or exclusivity rights. However, tentative approval makes the product eligible to be considered for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR) program.

The lamivudine/zidovudine fixed dose combination tablets are a version of the FDA approved Combivir tablets 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


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SOURCE: Food and Drug Administration (FDA).

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