Myfortic mycophenolic acid regulatory update

FDA approved a single REMS for all immunosuppressants containing mycophenolate to address the risks of first-trimester miscarriage and congenital birth defects. The REMS includes an education program for prescribers, a medication guide, a registry for pregnant women and educational tools to help prescribers counsel women on the risks of the drugs. FDA said the training program is not mandatory for prescribers, citing the potential for delaying treatment. Drugs covered by the REMS include Novartis' Myfortic mycophenolic acid and CellCept mycophenolate mofetil from Roche (SIX:ROG; OTCQX:RHHBY, Basel, Switzerland), as well as generic formulations of mycophenolate. ...