Posted from: Thursday, February 07, 2019 - 05:25 PM - Present

Record Number of Novel Drug Approvals in 2018

January 8, 2019 – The U.S. FDA has set a new record for novel drug approvals in a single year, having granted approval to 59 novel drugs through the Center for Drug Evaluation and Research (CDER) in 2018. This breaks the previous record of 53 novel drug approvals in a single year, which was set in 1995.

In addition to the novel drug approvals through CDER, the FDA approved three new drug products in 2018 through the Center for Biologic Evaluation and Research (CBER). Of the 62 new drugs approved through CDER and CBER, 34 were for rare or orphan conditions, 18 for oncology, and 15 were designated as breakthrough therapies. The year also saw the approval of a new vaccine, Merck and Sanofi’s Vaxelis™, which is the first six-in-one vaccine ever to receive FDA approval. Seven new biosimilars also received FDA approval in 2018.

The FDA has issued a report detailing 2018’s novel drug approvals, as well as notable FDA-approved expanded indications, new formulations, and new dosage forms. The report can be found at:


Last Updated Monday, October 21, 2019 - 12:31 PM.