August 5, 2013
FDA OKs Generic Truvada for Use Abroad
The U.S. Food and Drug Administration (FDA) has approved a generic version of Gilead Sciences’ HIV antiretroviral Truvada for use outside the United States. Strides Arcolab Limited of Bangalore, India, will manufacture tablets made of emtricitabine and tenofovir disoproxil fumarate, the two meds found in Truvada. The drugs received an expedited review process thanks to the President’s Emergency Plan for AIDS Relief (PEPFAR).
Patent protection forbids the current sale of generic Truvada within the United States, but this approval by the FDA, given because the two generic drugs meet all required quality, safety and efficacy standards, green-lights their use in the resource-poor nations that PEPFAR serves. Considering the World Health Organization’s shift in treatment guidelines—it raised the CD4 threshold for beginning therapy from 350 CD4 cells to 500—the approval of a less expensive version of Truvada is an important cost-savings measure.
To read the FDA release, click here.
Search: U.S. Food and Drug Administration, FDA, Gilead Sciences, Truvada, emtricitabine, tenofovir disoproxil fumarate, Strides Arcolab Limited, PEPFAR, World Health Organization.
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