fda-approval-letter
PHARMACY

ViiV Healthcare’s Dovato gets FDA nod

BY Sandra Levy

The Food and Drug Administration has approved ViiV Healthcare’s Dovato (dolutegravir and lamivudine). The drug has been approved as a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.

This is the first FDA approved two drug, fixed dose, complete regimen for HIV-infected adults who have never received treatment for HIV.

“Currently, the standard of care for patients who have never been treated is a three-drug regimen. With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug,” director of the division of antiviral products Debra Birnkrant said. “Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time.”

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