DCGI Approves Hetero's Generic FDC Drug 'Darunavir + Ritonavir'

Hetero, one of India's leading generic pharmaceutical companies and the largest producer of anti-retroviral drugs, has received the approval from Drug Controller General of India (DCGI) to launch the first-ever generic fixed-dose combination (FDC) drug 'Darunavir + Ritonavir' in India.

The product will be marketed and distributed under the brand name 'Danavir-R' in India by Hetero Healthcare Ltd. It will be made available in three strengths - 800/100mg, 600/100mg and 400/50mg.

The FDC drug 'Darunavir+Ritonavir' is an anti-retroviral medication indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adult patients. This first-ever drug combination, a once-daily dose, simplifies the patient's treatment with one tablet taken every day along with other anti-retroviral agents, ensuring that the drugs are taken in correct proportions. This '2-in-1' combination therapy improves the patient's adherence to treatment, while improving the quality of life.

In line with Hetero's commitment in making HIV/AIDS drugs affordable and accessible to patients globally, the company also looks forward to make this product available in other countries, subject to approvals from respective regulatory authorities.