NATCO gets ANDA approval for Cabazitaxel Intravenous Solution

Breckenridge and Natco did not divulge any more details regarding the launch date for the product

Natco Pharma announced that the US Food and Drug Administration (US FDA) has granted approval to its partner Breckenridge Pharmaceutical Inc’s Abbreviated New Drug Application (ANDA) for Cabazitaxel Intravenous Powder (generic for Jevtana Kit) for the 60mg/1.5mL (40mg/mL) strength.

A company statement informed that 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. According to industry sales data, Jevtana Kit generated annual sales of $303 million during the twelve months ending May 2022.

ANDA approvalBreckenridge Pharmaceutical IncCabazitaxel Intravenous SolutionJevtana KitNatco PharmaUS FDA
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