Posted by Michael Wonder on 02 Jun 2021
Bausch Health and Clearside Biomedical announce U.S. FDA filing acceptance for Xipere (triamcinolone acetonide suprachoroidal injectable suspension)
2 June 2021 - PDUFA action date Is 30 October 2021.
Bausch Health Companies along with Clearside Biomedical announced today that the U.S. FDA has accepted the resubmitted new drug application for Xipere (triamcinolone acetonide suprachoroidal injectable suspension).
The FDA determined that the filing is a Class 2 resubmission and therefore assigned a Prescription Drug User Fee Act action date of 30 October 2021.
