In calendar year 2015, FDA’s Center for Drug Evaluation and Research (CDER) approved 45 novel new drugs, approved as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs). 

Novel new drugs are often innovative products that serve previously unmet medical needs or otherwise significantly help to advance patient care and public health.  NMEs have chemical structures that have never been approved before.  However, in some cases an NME may have actions similar to earlier drugs and may not necessarily offer unique clinical advantages over existing therapies.  This report summarizes all of the 2015 NME and novel new BLA approvals, emphasizing those that offer new and innovative treatments to patients in need.


Posted on the FDA website on 5 January 2016