Generic Industry Consolidation Illustrated In ANDA Holder List
Most of US FDA's approved ANDAs are owned by a handful of firms, while the vast majority of owners have between one and five.
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FDA is again relying on sponsor self-reporting as it launches GDUFA II.
GDUFA II's fee structure shifts burden from manufacturers to sponsors though 'ANDA holder fee.'
Since applications comprise most of the workload, they will be the focus in the next generic drug user fee cycle.