ANDA Submissions Continue Yo-Yo Pattern, Unlike Approvals
After spike in March, generic drug application submissions drop 62% in April, while approval volume remains at monthly average.
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Jump in March may have been "happenstance," but also could be concerning as US ANDA submissions reach near record pace.
As more generic applications arrive, Office of Generic Drugs staff may have a tougher time reaching review goals.
US FDA receives more than 100 ANDAs during the first month of GDUFA year five, suggesting sponsors want the new 10-month review goal and cheaper user fee.