Hetero gets approval for Hepatitis C drug

Hyderabad, May 5 : Hetero, a leading Indian generic pharmaceutical firm and the world's largest producer of anti-retroviral drugs, on Friday said it has got the approval to make the generic version of a Hepatitis C drug.

The approval came from the Drugs Controller General of India.

The product "Sofosbuvir+Velpatasvira" will be marketed and distributed under the brand name "Velasof" in India by Hetero Healthcare Ltd, the company said in a statement.

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 to treat patients with chronic hepatitis C genotype 1 to 6, the statement said.

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