NDA filing accepted for Yonsa by the US FDA

The New Drug Application (NDA) for Yonsa (abiraterone acetate) ultramicrosize tablets has been accepted for filing by the US Food and Drug Administration, says privately-held company Churchill Pharmaceuticals.

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of March 19, 2018 to complete its review.

Abiraterone is the active ingredient of prostate cancer drug Zytiga, which is marketed by US healthcare giant Johnson & Johnson’s (NYSE: JNJ) Janssen subsidiaries. Yonsa Tablets ultramicrosize have double the bioavailability of the comparator formulation of abiraterone acetate, according to Churchill, which is focused on providing value to cancer care by developing quality orally delivered oncology products with optimized clinical profiles.