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Lupin receives US FDA tentative approval for generic Symtuza tablets

Our Bureau, Mumbai
Monday, February 3, 2025, 13:45 Hrs  [IST]

Global pharma major Lupin Limited (Lupin) announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for darunavir, cobicistat, emtricitabine, and tenofovir alafenamide tablets, 800 mg/150 mg/200 mg/10 mg. This ANDA has been found to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Symtuza tablets, 800 mg/150 mg/200 mg/10 mg of Janssen Products, LP. Lupin is the exclusive first-to-file for this product. The product will be manufactured at Lupin’s Nagpur facility in India.
 
Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide tablets (Symtuza) had estimated annual sales of USD 1,374 million in the US (IQVIA MAT December 2024).
 
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

 

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