Hetero gets DCGI nod to market anti-retroviral FDC tablets
New Delhi: Drug firm Hetero said it has received the Drug Controller General of India's approval to launch generic fixed-dose combination anti-retroviral drug 'Darunavir + Ritonavir' in the country.
The product will be marketed and distributed under the brand name 'DANAVIR-R' in India by Hetero Healthcare Ltd, the Hyderabad-based firm said in a statement.
It will be made available in the strengths of 800/100mg, 600/100mg, and 400/50mg, it added.
Commenting on the development, Hetero Group of Companies CMD B P S Reddy said: "Hetero is proud to extend its latest offering Darunavir+Ritonavir FDC in three strengths for HIV/AIDS patients."
The company also looks forward to making these tablets available in other countries, subject to approvals from respective regulatory authorities, Hetero said.
The product is an anti-retroviral medication indicated for the treatment of human immunodeficiency virus (HIV-1) in adult patients, it added.
anti-retroviralapprovalDANAVIR-RDarunavir + RitonavirDCGIDrug Controller General of IndiaFDC tabletsFixed Dose CombinationgenericHeteroHetero Healthcare LtdHIV-1HIV/AIDShuman immunodeficiency virusLaunchmarketSource : PTI