Digitalis lanata that is extracted from "Digitalis lanata". It is used to treat some heart conditions such as atrial fibrillation. It slows atrioventricular conduction so that the heartbeat slows down and slightly increases contraction power (positive inotropic effect). Because of the improved circulation in congestive heart failure caused by fast atrial fibrillation, the kidneys can function better, which stimulates the flow of urine, which lowers the volume of the blood and lessens the load on the heart. This is the effect that was first described when the plant was discovered as a medicine (Withering 1785). Digitalin was not discovered until the mid-19th
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