FDA gives tentative approval to Aurobindo’s Tivicay generic

SILVER SPRING, Md. — The Food and Drug Administration has granted its tentative approval to Aurobindo Pharma for its generic of Tivicay (dolutegravir or DTG), making it the first approval for a generic of the HIV treatment recommended by the World Health Organization and the Centers for Disease Control and Prevention. 

 

“The approval of the generic version of DTG shows the commitment towards the larger cause of bringing affordable HIV drugs to millions of people,” Aurobindo managing director N. Govindarajan said. “This is a one-of-its-kind agreement between innovator and generic company where the generic version of the drug will be launched in around three years from the originator product. Further, we are also developing a fixed-dose combination of DTG.” 

 

Because of a licensing with Tivicay maker ViiV Healthcare allowing the generic to launch in 92 licensed countries after getting regulatory approval and the Clinton Health Access Initiative, Aurobindo expects its product to launch in sub-Saharan Africa in late 2016. 

 

“Dolutegravir is a critical new tool that will help us achieve the UNAIDS 90-90-90 goals and an AIDS-free generation,” Clinton Health Access Initiative EVP David Ripin said. “The WHO included Dolutegravir in its recommendations for first-line therapy in 2015, and we expect rapid growth in demand now that a cost-effective generic product is available. Dolutegravir, taken with other HIV treatments, has the potential to improve the lives of millions of patients.”