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Generic pharmaceuticals and anti retroviral drug manufacturer Hetero has received approval for the fixed dose combination drug Ledipasvir sofosbuvir from the Drug Controller General of India (DCGI).
The drug, Ledisof, is a generic version of Gilead Sciences’ brand Harvoni which is approved by the US FDA.
The Hyderabad based Hetero had singed a non-exclusive licensing agreement with Gilead in September last year to manufacture and market the drug indicated for the treatment of chronic hepatitis C and is the first company to receive DCGI approval for this category of drug.
``We are happy to extend the fixed dose combination therapy Ledipasvir sofosbuvir (Ledisof) to Indian patients which is much more effective than Sofosbuvir,’’ B P S Reddy, Chairman and Managing Director of Hetero said in a release issued here on Monday.
Hepatitis C is a growing health concern in many developing countries including India which is estimated to have about 12 to 18 million people infected with hepatitis C.
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