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08/05/2022

Breckenridge obtains FDA nod for generic Jevtana

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.
Sandra Levy
Senior Editor
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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.

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