Breckenridge obtains FDA nod for generic Jevtana
Breckenridge has received the Food and Drug Administration’s permission for cabazitaxel intravenous powder, the generic of Sanofi's Jevtana Kit.
The product was developed in collaboration with Natco Pharma.
Jevtana is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.
[Read more: Breckenridge gets FDA nod fore 2 generics]
Breckenridge received final approval for the 60 mg/1.5 ml (40 mg/ml) strength.
Breckenridge and Natco Pharma said that they are unable to comment on the launch date for the product, as “that is confidential and cannot be disclosed at this time.”
[Read more: Breckenridge signs multiproduct agreement with Welding]
The Jevtana Kit had a market value of $303 million during the 12 months ending May 2022, according to industry data.