Hetero gets DCGI nod for generic chronic hepatitis C drug
New Delhi: Drug firm Hetero said it has received nod from the regulator DCGI for its generic Sofosbuvir and Velpatasvir combination tablets used for treatment of chronic hepatitis C.
The company "has received the approval for the generic version of 'Sofosbuvir+Velpatasvir' combination from the Drugs Controller General of India (DCGI)", Hetero said in a statement.
The product will be marketed and distributed under the brand name 'Velasof' in India by Hetero Healthcare Ltd, it added.
"This fixed-dose combination is the generic version of Gilead's brand Epclusa, approved by the USFDA for the treatment of patients with chronic hepatitis C genotype 1 to 6," Hetero 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.
The company "has received the approval for the generic version of 'Sofosbuvir+Velpatasvir' combination from the Drugs Controller General of India (DCGI)", Hetero said in a statement.
The product will be marketed and distributed under the brand name 'Velasof' in India by Hetero Healthcare Ltd, it added.
"This fixed-dose combination is the generic version of Gilead's brand Epclusa, approved by the USFDA for the treatment of patients with chronic hepatitis C genotype 1 to 6," Hetero 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.
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