Digitalis digitalis. As a result of increased contractility, stroke volume is increased. Ultimately, digitalis increases cardiac output (Cardiac Output=Stroke Volume x Heart Rate). This is the mechanism that makes this drug a popular treatment for congestive heart failure, which is characterized by low cardiac output. Digitalis also has a vagal effect on the parasympathetic nervous system, and as such is used in re-entrant cardiac arrhythmias and to slow the ventricular rate during atrial fibrillation. The dependence on the vagal effect means digitalis is not effective when a patient has a high sympathetic nervous system drive, which is the case with acutely
New Drug Application Review should complete within 6 months. The decision comes in a "Complete Response Letter". Biologics, such as vaccines and many recombinant proteins used in medical treatments are generally approved by FDA via a Biologic License Application (BLA), rather than an NDA. The manufacture of biologics is considered to differ fundamentally from that of less complex chemicals, requiring a somewhat different approval process. Generic drugs that have already been approved via an NDA submitted by another maker are approved via an Abbreviated New Drug Application (ANDA), which does not require all of the clinical trials normally required for a new drug