New Delhi: Drug major Sun Pharmaceutical Industries’ subsidiary has received approval from the US health regulator for YONSA, used for the treatment of a form of prostate cancer.
Sun Pharma had acquired YONSA from Churchill Pharmaceuticals and will commercialize the drug in the US.
In a regulatory filing, Sun Pharma and Churchill Pharmaceuticals, LLC said, “one of Sun Pharma’s wholly owned subsidiary companies has received approval from the US Food and Drug Administration (USFDA) for YONSA.”
YONSA (abiraterone acetate) is a novel formulation in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC), the company said.
Sun Pharma said Churchill is eligible to receive upfront and sales-linked milestone payments as well as royalties on sales pursuant to an agreement between the two companies to commercialize YONSA in the US.
YONSA in combination with methylprednisolone was filed as a new drug application (NDA) and will be promoted as a branded product in the US, Sun Pharma added.