Aurobindo Pharma gets USFDA approval for HIV drug
The pharma company has received final approval from the USFDA, US Food and Drug Administration to manufacture and market 600 and 800 mg Darunavir tablets, said the Hyderabad-based drug maker.
Aurobindo Pharma on Wednesday announces that its generic medication for the treatment of human immunodeficiency virus (HIV-1) infection has been approved by the US health regulator.
The pharma company has received final approval from the USFDA, US Food and Drug Administration to manufacture and market 600 and 800 mg Darunavir tablets, said the Hyderabad-based drug maker.
"The company's product is therapeutically equivalent to the reference listed drug (RLD), Prezista tablets, 600 mg and 800 mg, of Janssen products, LP," it added.
The product will be launched on November 29, Wednesday, confirmed the drug firm. 600 and 800 mg Darunavir tablets, in combination with other antiretroviral agents, can be helpful for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older.
The approved product has an estimated market size of USD 274.8 million for the 12 months ended October 2023.Aurobindo noted that it now has a total of 500 Abbreviated New Drug Application (ANDA) approvals from the USFDA, says IQVIA data.
(With input from PTI)
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