New Delhi, Nov 29: Aurobindo Pharma on Wednesday mentioned it has acquired approval from the US well being regulator to market a generic medicine for the remedy of human immunodeficiency virus (HIV-1) an infection.
The corporate has acquired closing approval from the US Meals and Drug Administration (USFDA) to fabricate and market Darunavir tablets in strengths of 600 mg and 800 mg, the Hyderabad-based drug maker mentioned in a regulatory submitting.
The corporate’s product is therapeutically equal to the reference listed drug (RLD), Prezista tablets, 600 mg and 800 mg, of Janssen merchandise, LP, it added.
The product will probably be launched on Wednesday, the drug agency mentioned.
Darunavir tablets, 600 mg and 800 mg, together with different antiretroviral brokers, are indicated for the remedy of HIV-1 an infection in grownup and pediatric sufferers 3 years of age and older.
As per IQVIA information, the permitted product has an estimated market measurement of USD 274.8 million for the 12 months ended October 2023.
Aurobindo famous that it now has a complete of 500 Abbreviated New Drug Software (ANDA) approvals from the USFDA. (PTI)
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