Abstract: Objective: To analyze the novel drugs approved by U.S. Food and Drug Administration (FDA) in 2017 so as to provide references for drug regulators and new drug researchers. Methods: The information of the novel drugs approved by FDA in 2017 and over the years was collected form FDA official website and was analyzed. Results Conclusion: FDA approved a total of 46 novel drugs in 2017, including 34 new drug applications and 12 biologics license applications. The number of approval in 2017 was the highest value in the last 10 years. There were 15 first-in-class and 18 orphan designees in the approval cohort. The main therapeutic fields were antitumor drugs, anti-infectious drugs and drugs for nervous system. The main dosage forms of the novel drugs were injections and tablets．