Natco partner bags USFDA nod for Cabazitaxel Intravenous Powder
Hyderabad: Natco Pharma Limited today announced that the U.S. Food and Drug Administration (USFDA) has granted approval to its partner Breckenridge Pharmaceutical Inc's Abbreviated New Drug Application for Cabazitaxel Intravenous Powder (generic for Jevtana Kit) for the 60mg/1.5mL (40mg/mL) strength.
The product is used for the treatment of prostate cancer. Cancer is a large group of diseases that can start in almost any organ or tissue of the body when abnormal cells grow uncontrollably, go beyond their usual boundaries to invade adjoining parts of the body and/or spread to other organs. Prostate cancer is cancer that occurs in the prostate. Prostate cancer is the most common type of cancer in men.
"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 release stated.
According to industry sales data, Jevtana Kit generated annual sales of $303 million during the twelve months ending May 2022.
Read also: Natco Pharma partner Viatris to launch first generic version of Nexavar tablets in US
Natco Pharma Limited was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million.
The company has seven manufacturing facilities spread across India with modern research laboratories, capabilities in New Drug Development, etc
Read also: Natco Pharma gets CDSCO nod to manufacture, market anti neoplastic drug Idelalisib
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