Thursday, 20 September 2018

Sun Pharma announces USFDA approval for YONSA

23 May 2018 | News

YONSA was shown in clinical studies to be an effective form of abiraterone acetate, and can be taken with or without food, in combination with methylprednisolone.

Source: pxhere

Source: pxhere

Sun Pharmaceutical Industries has announced that one of Sun Pharma’s wholly owned subsidiary companies has received approval from the U.S. Food and Drug Administration for YONSA, a novel formulation in combination with methylprednisolone, for the treatment of patients with metastatic castration-resistant prostate cancer.

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 U.S.

Churchill Pharmaceuticals is focused on providing value to cancer care by developing quality orally delivered oncology products with optimized clinical profiles. Churchill has a license from iCeutica to the SoluMatrix Fine Particle Technology, a proprietary manufacturing process that may unlock the potential of certain oral drugs by changing how well they dissolve and how efficiently they are absorbed.

“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 U.S.

 

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