Natco gets DCGI approval to launch hepatitis C drug
New Delhi-based Natco Pharma Ltd. on Tuesday announced that it has received approval for the generic version of ledipasvir and sofosbuvir combination from Drugs Controller General India (DCGI). NATCO plans to launch this combination drug under its brand name Hepcinat LP. The medicine will be used for the treatment of chronic Hepatitis C (CHC) genotype 1 infection in adults. The medicine contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet and is sold globally by Gilead Sciences - a US based biotechnology firm. Ledipasvir and Sofosbuvir is a two-drug fixed-dose combination product that will be sold under the brand name HARVONI. “This single-tablet regimen is the first of its kind to offer significantly higher cure rates in Genotype-1 CHC infection compared to conventional therapies. Natco will price its generic medicine, Hepcinat LP, at an MRP of Rs.25,000 for a bottle of 28 tablets,” Natco Pharma said. NATCO was the first licensed company to launch the generic version of this combination drug in Nepal. Earlier, NATCO had signed a non-exclusive licensing agreement with Gilead Sciences, to manufacture and sell generic versions of its chronic hepatitis C medicines, including generic version of HARVONI. The company can now sell this medicine in 100 other developing countries besides India.
December 15, 2015 | 04:35pm IST