Digitalis obscura Digitalis obscura Digitalis obscura is a flowering plant, commonly known as the sunset foxglove or willow-leaved foxglove. It is native to regions in Spain and Africa, but can be grown as an ornamental flower around the world. It is a perennial woody plant belonging to the family Plantaginaceae. (Along with the other foxgloves it used to be placed in the figwort family, Scrophulariaceae; however, recent genetic research has moved the genus "Digitalis" to a larger family.) The sunset foxglove is similar to many of the foxglove species in its high toxicity and medicinal use as a source for the heart-regulating
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