Welcome to the FDA’s Center for Drug Evaluation and Research’s (CDER’s) sixth annual Novel Drugs Summary.
Each 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. 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. However, a small subset of these new approvals, referred to as novel drugs, are among the more innovative products that often help advance clinical care to another level. At the end of each calendar year, CDER summarizes these new products.
Our annual summary reports the number of novel drugs approved. However, we also focus on the medical value 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. In 2016, novel approvals include the first treatment for patients with spinal muscular atrophy, the first drug approved to treat Duchenne muscular dystrophy, a new drug to treat hallucinations and delusions in some people with Parkinson’s disease, a new drug to treat patients with a rare chronic liver disease known as primary biliary cirrhosis, and two new treatments for patients with hepatitis C. The field also includes new treatments for patients with ovarian cancer, bladder cancer, soft tissue sarcoma, and chronic lymphocytic leukemia—as well as two new diagnostic agents for detecting certain forms of cancer.