The US Food and Drug Administration has released Advancing Health through Innovation: 2018 New Drug Therapy Approvals, a summary of the Center for Drug Evaluation and Research’s (CDER’s) 2018 important new drug approvals that serve to bring innovative new drug therapies that are safe and effective to patients in need. While CDER approved 59 novel drugs in 2018, more than in any prior year, CDER, as always, focuses on the medical value of the approvals, not the number. We also approved new uses, new formulations, and new dosage forms for many already FDA-approved drugs that will help to advance patient care. This report emphasizes the many innovative regulatory tools CDER uses to enhance our efficiency and expedite the review and approval of drug therapies never marketed in the U.S. and that all these drugs were approved by or well before their goal dates as determined by the Prescription Drug User Fees Act (PDUFA).

 

This report also highlights biosimilar approvals that can lead to increased access to therapies and lower costs to patients. These new approvals will benefit patients affected by a wide range of rare diseases, neurological disorders, infectious diseases, cancers, and many other medical conditions. 

 

The report released today demonstrates CDER’s commitment to innovation, efficiency, safety and to improving and saving patients’ lives.

 

For more information, please visit: Novel Drug Approvals for 2018.