Today, FDA posted Advancing Health through Innovation: New Drug Approvals and Other Drug Therapy Advances 2019, a summary of the Center for Drug Evaluation and Research’s (CDER’s) notable new drug approvals to the American public, and illustrating CDER’s role in bringing innovative new drug therapies that are safe and effective to patients in need.
As with previous years, this year’s notable new drug therapies include a variety of novel drugs --- those never before approved or marketed in the United States. Novel drugs often represent important new therapies for advancing patient care.
Importantly, this report also goes beyond a discussion of novel approvals and includes an overview of an array of other notable approvals --- for instance, new approvals for uses of already FDA-approved drugs. Please take particular note of these other approvals. You will find, as in past years, that many important advances in drug therapy approved in 2019 use an already FDA-approved drug to treat a new disease beyond that for which it was originally approved or to treat a new population of patients, such as children.
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