GSK Coreg Labeling Cites 23% Mortality Risk Reduction In Post-MI Indication
GlaxoSmithKline's Coreg labeling states that data show a mortality risk reduction of 23% in patients taking the drug after suffering a myocardial infarction
You may also be interested in...
Proactive US FDA Propelled Review Of Genentech’s Actemra In Systemic Sclerosis Amid Evolving Regulatory Landscape
Pink Sheet’s Drug Review Profile series looks at the unusual history of a systemic sclerosis interstitial lung disease indication for Genentech’s Actemra that was revived at the FDA’s behest and vetted by CDER’s high-level CDER policy council.
Spironolactone Starts Out On ‘Unusual But Not Unprecedented’ Regulatory Path, Thanks To US FDA Reviewers
Despite the lack of a sponsor or an application, FDA’s cardio-renal advisory committee will consider a possible new indication for the generically available drug in heart failure with preserved ejection fraction (HFpEF), driven by agency analysis of the NIH-sponsored TOPCAT trial.
GSK Coreg Post-MI Survival Backed By Beta Blocker Experience – FDA Cmte.
GlaxoSmithKline's Coreg use in the reduction of post-myocardial infarction mortality is supported by previous experience with other beta blockers in that setting, FDA's cardiovascular advisory committee said