HYDERABAD, DEC 8: Generic pharmaceutical company Hetero today announced that it has received the approval for the fixed-dose combination Ledipasvir-Sofosbuvir (90mg/400mg) 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 signed 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.
We expect approval for other Indian generics manufacturers to follow soon.