Generic Companies Race To Withdraw ANDAs
Industry consolidation may be a reason ANDA withdrawals have increased during GDUFA II.
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Generic Application Mystery: Few ANDAs Withdrawn To Start FY 2023
In past years, sponsors have pulled ANDAs at the beginning of a fiscal year in part to control their GDUFA program fee payments, but no approved ANDAs were withdrawn during the first two months of FY 2023.
December ANDA Rush Is Largest In Two Years
December's ANDA rush has provided the largest monthly haul in two years. However, the month may be losing its influence over the US FDA's annual submission total.
December ANDA Rush Is Largest Monthly Haul In Two Years
However, the month may be losing its influence over the US FDA's annual submission total.