eChapter 2018: Goodman & Gilman Year in Review New and Noteworthy FDA Regulatory Actions

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.