Aurobindo Pharma receives USFDA approval for a generic HIV-1 medication, Darunavir tablets in 600 mg and 800 mg strengths. The approved product is therapeutically equivalent to the reference listed drug, Prezista tablets by Janssen products.
The drug firm plans to launch Darunavir tablets on the same day as the approval announcement.
Indicated for treating HIV-1 infection in patients aged 3 years and older, the product will be launched in combination with other antiretroviral agents.
According to IQVIA data, the estimated market size for the approved product is USD 274.8 million for the 12 months ended October 2023. Aurobindo Pharma now holds a total of 500 Abbreviated New Drug Application (ANDA) approvals from the USFDA.
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