Digitalis thapsi Digitalis thapsi Digitalis thapsi, known commonly as Spanish foxglove, Spanish digitalis, and fingerhut foxglove, is a flowering plant in the genus "Digitalis" that is native to Spain. It was first described by Carl Linnaeus in 1753. It is of commercial importance as an ornamental plant. Hybrids with "D. purpurea" have proved successful and are fertile. Its yellow-green leaves are ovate to oblong in shape and decurrent, with winged bases. The flowers, stems and leaves are covered with tiny hairs, giving them a soft appearance. The leaves have non-glandular trichomes and a striated cuticle. The pink flowers are arranged in raceme
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