The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.
Today, the Food and Drug Administration released a summary of novel drugs approved by the agency’s Center for Drug Evaluation and Research (CDER) in calendar year 2015 as new molecular entities under new drug applications or as new therapeutic biologics under biologics license applications. Novel new drugs are often innovative products that serve previously unmet medical needs potentially adding significant clinical value to the care of thousands of patients – many with serious and life-threatening diseases. While the quantity of novel new drug approvals increased in 2015, our main focus continues to be on the unique qualities of many of these new drugs, their contribution to enhanced patient care, and the various regulatory tools the Agency employed to ensure their safe and efficient development and approval.
For more information, please visit: Novel New Drugs Summary 2015.