Digitalis grandiflora of Garden Merit. As the plant contains cardenolides, all parts are toxic. Its leaves contain 0.2% glycosides of the digitoxin-type and about 0,1% of the digoxin-type. Even so, the plant is not used in the production of cardiac glycosides. The Latin specific epithet "grandiflora" means “large flowered”. (Hybrid formula: "Digitalis grandiflora" Mill. × "Digitalis purpurea" L.). Digitalis grandiflora Digitalis grandiflora, the yellow foxglove, big-flowered foxglove, or large yellow foxglove, is a species of flowering plant in the genus "Digitalis", family Plantaginaceae (formerly Scrophulariaceae). It is native to southern Europe and Asia. In mountains it grows on warm, bushy slopes or
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