Entresto Approval Expands Use to More HF Patients With LVEF Below Normal
The approval was based on data from the double-blind, parallel-group, active-controlled phase 3 PARAGON-HF trial.
The approval was based on data from the double-blind, parallel-group, active-controlled phase 3 PARAGON-HF trial.
To compare the clinical benefits of these diuretics, the study authors conducted a literature search that reported on outcomes such as MACE and left ventricular mass.
Chemotherapy agents such as vincristine sulfate injection, vinblastine sulfate injection, and vinorelbine tartrate injection should only be prepared in IV infusion bags.
The Agency announced that additional clarification of clinical data was needed prior to completing the review.
The approval was based on data from the pivotal phase 3 EMPOWUR study.
The allocation and distribution of vaccine is being managed by the Department of Defense, in partnership with agencies within the Department of Health and Human Services.
The alert was based on data from three 20-week double-blind, placebo-controlled studies each with 34-week extensions.
Findings showed the study met the primary end point of reduction in cardiovascular death or heart failure events.
In a statement, the Company noted that the actions being taken are considered “routine” when an unexplained illness is reported in a clinical trial.
The long-acting human insulin analogue has an identical amino acid sequence to Lantus® (insulin glargine; Sanofi).