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U.S. Food and Drug Administration
Center of Drug Evaluation and Research
/drugs
NOVEL DRUGS
2015
JANUARY 2016
S U M M A R Y
IMPACT INNOVATION PREDICTABILITY ACCESS
NOVEL DRUGS 2015 SUMMARY
CONTENTS
INTRODUCTION 1
TEN-YEAR COMPARISON 2
IMPACT 4
INNOVATION 8
PREDICTABILITY 10
ACCESS 11
OVERVIEW 12
2015 APPROVALS 15
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
/drugs
For more details about the individual novel drugs, see pages 15-17.
INTRODUCTION 1
INTRODUCTION
Welcome to the FDA’s Center for Drug Evaluation
and Research’s (CDER’s) fifth 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 a
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