CellCept and Myfortic medguides to be part of REMS
This article was originally published in Scrip
Executive Summary
New medication guides explaining birth defect and serious infection risks with two transplant drugs, Roche's CellCept (mycophenolate mofetil) and Novartis's Myfortic (mycophenolic acid), could be the first step toward more restrictive risk management measures for the immunosuppressants.
You may also be interested in...
Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works
FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.
ADHD Drugs: FDA Commissioner Blames Inappropriate Prescribing For Shortages
ADHD drug shortages may have resulted from industry reticence to fill DEA quotas, as well as a 'heavy element of professional responsibility' with off-label prescribing, Robert Califf told a House appropriations subcommittee.
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.