Abstract: In calendar year 2012,the US Food and Drug Administration (FDA) approved 39 novel new drugs, known as new molecular entity (NMEs). This includes applications for 33 new drug applications (NDAs) and 6 biologics license applications (BLAs). We compared and analyzed the data in FDA web (http://www.fda.gov). The results are as follows：FDA approved 39 NMEs in 2012,the highest total for the last decade,which shows a trend towards increasing numbers of products approval；Applications for new drug approvals remain steady,and more than half of the NMEs approved in 2012 are identified by FDA as First-in-Class；The current focus for drug R D is still on the main therapeutic areas,such as antineoplastic drug,antimicrobial drugs,digestive system drugs,and hematological system drugs；Thirteen of the 39 NMEs are approved to treat rare or “orphan” diseases, this is significant because patients with rare diseases often has few or no drug treatment options；The main dosage forms of the approved drugs are tablets and injections；The sponsors approved new drugs are still the well-known companies in drug research and development.