Hetero gets DCGI approval to market Hepatitis C drug
Advertisement
New Delhi: Drug maker Hetero has received approval from DCGI to market generic version of Gilead's Harvoni, a drug used in the treatment of Hepatitis C, in the country.
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), the company said in a statement.
Following the non-exclusive licensing agreement signed with Gilead Sciences in September last year, to manufacture and market chronic hepatitis C medicines, Hetero is all set to launch the fixed-dose combination therapy Ledipasvir-Sofosbuvir for Indian patients, it added.
The product will be available under the brand name 'Ledisof'.
"We are now happy to extend the fixed-dose combination therapy Ledipasvir-Sofosbuvir (Ledisof) to Indian patients, which is much more effective than Sofosbuvir. With the launch of Ledisof, we look forward to bringing a paradigm shift in Hepatitis C management in the country", Hetero group of companies CMD BPS Reddy said.
This fixed-dose combination is the generic version of Gilead's brand Harvoni, approved by USFDA.
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.
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), the company said in a statement.
Following the non-exclusive licensing agreement signed with Gilead Sciences in September last year, to manufacture and market chronic hepatitis C medicines, Hetero is all set to launch the fixed-dose combination therapy Ledipasvir-Sofosbuvir for Indian patients, it added.
The product will be available under the brand name 'Ledisof'.
"We are now happy to extend the fixed-dose combination therapy Ledipasvir-Sofosbuvir (Ledisof) to Indian patients, which is much more effective than Sofosbuvir. With the launch of Ledisof, we look forward to bringing a paradigm shift in Hepatitis C management in the country", Hetero group of companies CMD BPS Reddy said.
This fixed-dose combination is the generic version of Gilead's brand Harvoni, approved by USFDA.
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.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.