Digitalis purpurea In other words, at precisely the right dosage, "Digitalis" toxin can cause the heart to beat more strongly. However, digitoxin, digoxin and several other cardiac glycosides, such as ouabain, are known to have steep dose-response curves, i.e., minute increases in the dosage of these drugs can make the difference between an ineffective dose and a fatal one. Symptoms of "Digitalis" poisoning include a low pulse rate, nausea, vomiting, and uncoordinated contractions of different parts of the heart, leading to cardiac arrest and finally death. The plant is popular as a garden subject, and numerous cultivars have been developed with a
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