Penstemon digitalis which repeat with two flowers multiple times. The pedicels are almost one fourth of an inch long and produce 1.25 inch long two-lipped tubular flowers over dark green foliage. The plant has elliptic basal leaves and lance-shaped to oblong stem leaves. It is called beardtongue because the plant has a fifth stamen which resembles a hairy beard due to having small hairs. "Penstemon" is a combination of the Greek words, "penta", "five" and "stemon", referring to the stamen, every flower containing five stamens. Four of the stamens are fertile while the fifth one is sterile. The Latin word "digitalis" means
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