Hetero receives generic ‘Sofosbuvir+Velpatasvir’ approval from DCG(I)

Hetero has received the approval for the generic version of ‘Sofosbuvir+Velpatasvir’ combination from Drugs Controller General (India) (DCGI). The product will be marketed and distributed under the brand name ‘Velasof’ in India by Hetero Healthcare.

Sofosbuvir+Velpatasvir is a two-drug fixed dose combination product that contains 400mg of Sofosbuvir and 100mg of Velpatasvir in a single tablet. This fixed-dose combination is the generic version of Gilead’s brand Epclusa, approved by US FDA for the treatment of patients with chronic hepatitis C genotype 1 to 6.

This product will be launched under the non-exclusive licensing agreement with Gilead Sciences, which allows to manufacture and sell generic versions of its chronic hepatitis C medicines in 101 developing countries.