BPI's Generic Mycophenolate Mofetil Hydrochloride Receives Receives Approval in the U.S.
Steriscience's Generic Mycophenolate Mofetil Hydrochloride Receives Approval in the U.S.
Novartis Pharmaceuticals Corp will pay $390 million to settle U.S. charges that it paid specialty pharmacies illegal kickbacks in exchange for inducing patients to refill certain medications, according to an accord announced Friday.
Mycophenolate is a human teratogen, which increases the risk of spontaneous abortions and congenital malformations following exposure during pregnancy.nNew contraindications will be added to the CellCept® (mycophenolate mofetil) and MYFORTIC® (mycophenolate sodium) Canadian Product Monographs to strengthen safety information for use:nduring pregnancy due to the mutagenic and teratogenic potentialnin women of childbearing potential who are not using highly effective contraceptive methodsnin women who are breastfeedingnHealthcare professionals should ensure that women and men taking mycophenolate products understand the risk of harm to the baby, the need for effective contraception, and the need to immediately consult a physician if there is a possibility of pregnancy.