Berlin, Connecticut, August 1, 2022
Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Cabazitaxel Intravenous Powder (generic for Jevtana Kit®). This product was developed in collaboration with Natco Pharma Limited. Breckenridge received final approval for the 60mg/1.5mL (40mg/mL) strength. 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.
