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Mylan receives tentative FDA approval for combination HIV treatment

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Mylan receives tentative FDA approval for combination HIV treatment

The U.S. Food and Drug Administration granted tentative approval to Mylan NV's combination HIV treatment that is made up of components found in ViiV Healthcare Ltd.'s Tivicay and Gilead Sciences Inc.'s Descovy.

Mylan was granted the approval under the U.S. President's Emergency Plan for AIDS Relief for its new drug application for dolutegravir, emtricitabine and tenofovir alafenamide tablets.

The global pharmaceutical company manufactures the products under licenses from the Medicines Patent Pool and Gilead Sciences, respectively.

Mylan said the treatment will be immediately available in developing countries as a first-line regimen for people being treated for HIV/AIDS.

This is the first tentative approval of tenofovir alafenamide and comes just two years after the FDA's approval of Descovy.

The combination is included as a recommended initial regimen for most people with HIV in the HIV guidelines of the U.S. Department of Health and Human Services.