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FDA grants tentative approval to abacavir
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The FDA has granted tentative approval to 60-mg abacavir tablets when combined with other HIV antiretrovirals, according to a press release.
The tablets — manufactured by Matrix Laboratories Limited in Hyderabad, India — are intended for pediatric use, allowing dosing for patients weighing as little as 5 kg, and may be dispersed in liquid for patients unable to swallow tablets.
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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