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PART 2: OTHER NOTEWORTHY FDA REGULATORY ACTIONS

Abbreviations

BLA: Biologic license application

FDA: U.S. Food and Drug Administration

NDA: New drug application

 

Note: The following symbols are used throughout.

! accelerated approval (final FDA approval is contingent on demonstration of a clinical benefit in a confirmatory trial)

biologic license designation

$ breakthrough therapy

# cancer drug

orphan indication

In the first half of 2019, the FDA granted 11 noteworthy NDA licenses and approved 14 noteworthy new BLAs. Part 1 of this series looked back at first-in-class and “me-too” NDA and BLA approvals, breakthrough ($) therapies, orphan indications (), cancer drugs (#), and companion diagnostics for precision cancer therapy. The remaining noteworthy FDA accomplishments are compiled in this part of the series, including dosing and other labeling changes approved for established drugs (Table P2-1), approved follow-on products, pediatric and pregnancy labeling changes, and other noteworthy FDA regulatory accomplishments related to drug efficacy and safety.

Table P2-1.Marketed Drugs With Notable Labeling Changes Approved January-June, 2019

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