For the second consecutive year, we approved more “orphan” drugs for rare diseases than any previous year in our history. In the area of infectious disease, our approvals include new treatments for urinary tract infections and chronic hepatitis C. We also approved new drugs for the treatment of patients with cystic fibrosis, and irritable bowel syndrome. This year’s field also includes new drugs to treat heart failure and high cholesterol, as well as the first approved reversal agent for a commonly-used blood thinner. We approved many new drugs to treat various forms of cancer, including four to treat multiple myeloma, and others to treat lung, skin, breast, brain, colorectal, and other cancers.
This year’s field of novel drugs will offer much to patients in need. However, we also focus on the quality of many of these new drugs, their contributions to enhanced patient care, and the various regulatory tools CDER used to help ensure their safe and efficient development and approval.
Our annual summary reports the quantity of novel drugs that we approved. At the end of each calendar year, CDER summarizes these new products. However, products in a small subset of these new approvals, that we refer to as novel drugs, are among the more truly innovative products that often help advance clinical care to another level.
These new products contribute to quality of care, greater access to medication, more consumer choice, and a competitive marketplace that enhances affordability and public health. Welcome to the FDA’s Center for Drug Evaluation and Research’s (CDER’s) fifth annual Novel Drugs Summary.Įach year, CDER approves hundreds of new medications, most of which are variations of previously existing products, such as important new dosage forms of already-approved products, or cost-saving generic formulations. Center for Drug Evaluation and Research Introduction
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