Digitalis purpurea Digitalis purpurea Digitalis purpurea (foxglove, common foxglove, purple foxglove or lady's glove) is a species of flowering plant in the plantain family Plantaginaceae, native to and widespread throughout most of temperate Europe. It is also naturalised in parts of North America and some other temperate regions. The plants are well known as the original source of the heart medicine digoxin (also called digitalis or digitalin). "Digitalis purpurea" is an herbaceous biennial or short-lived perennial plant. The leaves are spirally arranged, simple, long and broad, and are covered with gray-white pubescent and glandular hairs, imparting a woolly texture. The foliage forms
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