Generic Fixed-dose Combination of Darunavir + Ritonavir Receives Approval from DCGI

Pharmacy Medical Cure Tablets Medications

Hetero, one of the world’s largest producer of anti-retroviral drugs, today announced that it 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.
Commenting on the approval, Dr. B.P.S. Reddy, CMD, Hetero Group of Companies said, “Hetero is proud to extend its latest offering ‘Darunavir+Ritonavir’ FDC in three strengths for HIV/AIDS patients. We will continue to invest in R&D capabilities and will develop such world-class anti-retroviral drug combinations in future.”
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.

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