Express Pharma

Sun Pharma gets US FDA nod for YONSA

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To treat metastatic castration-resistant prostate cancer in combination with methylprednisolone

Sun Pharmaceutical Industries and Churchill Pharmaceuticals announced that one of Sun Pharma’s wholly-owned subsidiary companies has received approval from the US Food and Drug Administration (FDA) for YONSA (abiraterone acetate), a novel formulation in combination with methylprednisolone, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

Churchill is eligible to receive upfront and sales-linked milestone payments, and royalties on sales from Sun Pharma pursuant to an agreement between the two companies to commercialize YONSA in the US.

“We are pleased to add YONSA to our growing oncology portfolio and continue to deliver on Sun Pharma’s commitment for enhanced patient access to innovative cancer therapies,” said Abhay Gandhi, CEO – North America, Sun Pharma.

YONSA in combination with methylprednisolone was filed as a New Drug Application (NDA) under the 505(b)(2) regulatory pathway and will be promoted as a branded product in the US.

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