Pure Encapsulations, a manufacturer of nutritional supplements, has launched PureResponse to help consumers enhance their immune balance and responsiveness.
The report is the first of its kind from the FDA’s Office of Generic Drugs, and notes that the FDA fully approved 843 Abbreviated New Drug Applications, issuing tentative approval to a further 184 ANDAs.
With this approval — which saw the drug given Priority Review, Breakthrough Therapy Designation and Orphan Drug Designation by the FDA — Rituxan becomes the first biologic therapy for the disease.
