Kedrion submits to FDA for Manufacture of RhoGAM/MICRhoGAM in Melville, NY

On Sep 30, 2019 Kedrion Biopharma Inc. (Kedrion Biopharma) met another milestone towards transferring the drug manufacture of RhoGAM/MICRhoGAM from Ortho Clinical Diagnostics (OCD), Raritan, NJ to Kedrion Biopharma’s Melville, NY facility. A robust Prior Approval Supplement (PAS) package was submitted and acknowledged by the FDA for review. The Prescription Drug User Fee Act (PDUFA) timelines for review and approval are typically 4 months from the date of acknowledgement of the PAS submission.

This is in addition to the already FDA approved fill and finish activities for products transferred from OCD to Kedrion Biopharma in March 2019.

With the potential approval of the transfer of the drug manufacturing by early 1st Qtr 2020, Kedrion Biopharma shall be licensed to manufacture, fill, finish and label the two products at our Kedrion Biopharma Melville, NY facility.

For more information please contact: [email protected]