Digitalis lanata beta blockers, angiotensin-converting enzyme inhibitors, and the calcium channel blocking agents. As new pharmacotherapeutic agents arise, the use of digitalis preparations is expected to continue to decline. There are also other commercial uses for "Digitalis lanata" other than heart conditions. For example, in South America the powdered leaves are used to relieve asthma, as sedatives, and as diuretics. In India it is included in an ointment that contains digitalis glycosides used to treat wounds and burns. Digitalis lanata Digitalis lanata (often called woolly foxglove or Grecian foxglove) is a species of foxglove. It gets its name due to the texture
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