Breckenridge Pharmaceutical’s Cancer Drug gets US FDA Approval

HEALTHCARE

The Food and Drug Administration (FDA) of the United States has approved Breckenridge Pharmaceuticals for Cabazitaxel Intravenous Powder, which is used to treat prostate cancer. Natco Pharma, partner of Breckenridge Pharmaceutical Inc. said the US FDA has approved the Abbreviated New Drug Application of Breckenridge for Cabazitaxel Intravenous Power with a 60mg/1.5 mL strength.

Natco said the introduction date for the product is confidential and both Natco and Breckenridge are unable to comment on the approval, and Jevtana Kit has also generated annual sales of 303 million dollars during the year ending May 2022.

Both companies have received final approval for the 10 mg and 60 mg strengths of the cancer drug, and have also received tentative approval for the 30 mg strength of the product. Natco Pharma said it believes the drug is eligible for 180 days of sole generic marketing exclusively for the 10 mg strength and has shared 180 days of generic marketing for the strength of 60 mg of the cancer drug at the time of launch.

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The company said by virtue of the settlement, Breckenridge and Natco have been granted a license permitting the launch of the generic carfilzomib product and may be released on a date that is held as confidential in 2027.