Myfortic mycophenolic acid regulatory update

FDA approved an updated label for Novartis' Myfortic mycophenolic acid to include a black box warning on embryofetal toxicity, malignancies and serious infections. The agency also added a warning stating that the use of Myfortic during pregnancy is associated with an increased risk of first trimester pregnancy loss and congenital malformations, and that female patients of childbearing potential must be made aware of the increased risks and counseled on pregnancy prevention and planning. The enteric-coated mycophenolate sodium is approved to prevent organ rejection in patients receiving allogeneic renal transplants in combination with cyclosporine and corticosteroids. ...