Showing posts with label Yonsa (abiraterone acetate). Show all posts
Showing posts with label Yonsa (abiraterone acetate). Show all posts

Wednesday, July 25, 2018

Sun Pharma Announces FDA Approval of Yonsa (abiraterone acetate) to Treat Metastatic Castration-Resistant Prostate Cancer

In continuation of my update on abiraterone acetate

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Sun Pharmaceutical Industries Ltd. and includes its subsidiaries and/or associate companies) and Churchill Pharmaceuticals, LLC. (Churchill) announced that one of Sun Pharma’s wholly owned subsidiary companies has received approval from the U.S. 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).

“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.