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FDA grants tentative approval to lamivudine/tenofovir combo
The FDA has granted tentative approval to a fixed-dose combination tablet that contains 300 mg lamivudine and 300 mg tenofovir disoproxil fumarate that will be co-packaged with 200 mg nevirapine, according to an FDA press release.
The tablet — which is manufactured by Matrix Laboratories Limited in Hyderabad, India — is approved for use alone or in combination with other therapies for the treatment of HIV-1 infection.
FDA grants tentative approval when it concludes that a drug meets all required quality, safety and efficacy standards but is not currently eligible for final approval for marketing in the US due to existing patents and/or exclusivity rights, according to the press release. However, under the President’s Emergency Plan for AIDS Relief (PEPFAR) stipulations, tentative approval allows the product to be purchased and used outside of the US.
Before granting tentative approval, the FDA conducts inspections of manufacturing facilities to determine that the facility is capable of producing a product that is the bioequivalent to other drugs with the same formulation.
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