REMS for CellCept and Myfortic could include pregnancy registry
This article was originally published in Scrip
Executive Summary
The US FDA continues to evaluate proposals by the makers of CellCept (mycophenolate mofetil; Roche) and Myfortic (mycophenolic acid; Novartis) as part of new risk evaluation and mitigation strategies (REMS) for ensuring safe use of the transplant products. A pregnancy registry is mentioned among several elements, according to an update by the agency on its website.