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Natco Pharma Ltd on Monday said its partner, Breckenridge Pharmaceutical Inc has received approval from the US health regulator for generic Cabazitaxel intravenous powder used in the treatment of prostate cancer.
The approval granted by the US Food and Drug Administration to Breckenridge Pharmaceutical Inc' is for the abbreviated new drug application for Cabazitaxel intravenous powder of strength 60mg/1.5ml (40mg/ml), the company said in a regulatory filing.
It is the generic equivalent of Jevtana Kit of Sanofi.
"Breckenridge and Natco are unable to make further comment regarding the launch date for the product, as that is confidential and cannot be disclosed at this time," the company said.
Citing industry data, Natco said Jevtana Kit generated annual sales of $303 million during the 12 months ended May 2022.
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