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PART 3: OTHER NOTEWORTHY REGULATORY ACTIONS

Note: The following symbols are used throughout.

orphan indications

$ breakthrough therapies

# cancer therapies

biologic license designations

 

In 2018, the U.S. Food and Drug Administration (FDA) granted 46 noteworthy new drug application (NDA) licenses and approved 29 noteworthy new biologic license applications (BLAs). Part 1 of this series looked back at first-in-class and “me-too” NDA approvals, breakthrough ($) therapies, orphan indications (), cancer drugs (#), and companion diagnostics for precision cancer therapy. Part 2 reviewed novel and “me-too” biologics licensed in 2018. The remaining 2018 noteworthy FDA accomplishments are compiled in this part of the series, including established drugs approved as new proprietary fixed-dose combinations or repurposed for novel uses (Table P3-1) and established drugs approved for expanded indications (Table P3-2). A compilation of other 2018 noteworthy FDA regulatory activities is provided below.

Table P3-1.Established Drugs Approved in 2018 as New Proprietary Fixed-Dose Combinations or Repurposed for Novel Uses

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