Digitalis purpurea nectar within. The fruit is a capsule which splits open at maturity to release the numerous tiny 0.1-0.2 mm seeds. The three subspecies of "Digitalis purpurea" are: Due to the presence of the cardiac glycoside digitoxin, the leaves, flowers and seeds of this plant are all poisonous to humans and some animals and can be fatal if ingested. Extracted from the leaves, this same compound, whose clinical use was pioneered by William Withering, is used as a medication for heart failure. He recognized it "reduced dropsy", increased urine flow and had a powerful effect on the heart. Unlike the purified
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