Hetero became first Indian company to receive DGCI’s approval for hepatitis C drug

Drug maker Hetero received the approval to market generic version of Gilead’s Harvoni which is  used in the treatment of Hepatitis C from USFDA(U S Food and Drug Administration). The product will be available under the brand name ‘Ledisof’.

Key facts :

• Hetero is the first company in India to receive the approval for the fixed-dose combination Ledipasvir-Sofosbuvir (90mg/400mg) from Drug Controller General of India (DCGI).
• In India alone, it is estimated that 12-18 million patients are infected with Hepatitis C which is several fold greater than those with HIV/AIDS.
• Untreated chronic hepatitis C increases the risk of cirrhosis of liver, liver failure and hepatocellular carcinoma.