CDER Approves 48 Drugs in 2019; 20% Less Than 2018

A very strong final quarter in 2019 led to CDER approving 48 new molecular entities in 2019. While this number is 20% off of last year’s record 59 approvals, it is well above the 10-year average of 35 annual approvals. The Center approved 44% (21 submissions) during October, November and December.

A quick look at the approvals shows that many of the novel approvals were for treating cancer and rare diseases. Many of the submissions benefited under FDA’s fast track program. This speeds new drug development and review by increasing communication between FDA and drug developers, and by enabling CDER to review portions of a drug application before it is fully submitted. CDER also designated many novel drugs in 2019 as breakthrough therapies. A breakthrough therapy designation includes all the fast track program features, as well as more intensive FDA guidance on an efficient drug development program.

To view a complete list of the approvals, click here.