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PART 2: OTHER NOTEWORTHY FDA REGULATORY ACTIONS

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 2021, the U.S. Food and Drug Administration (FDA) granted 21 noteworthy new drug application (NDA) licenses and approved 10 noteworthy new biologic license applications (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), licensed follow-on products, new combination product introductions, COVID-19 pandemic-related drug actions, market withdrawals, pediatric and pregnancy labeling changes, prescription-to-OTC switches, and other noteworthy FDA regulatory accomplishments related to drug efficacy and safety.

Labeling Changes

Table P2-1Marketed Drugs with Notable Labeling Changes Approved in the First Half of 2021

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