FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Expands ANDA Prioritization Policy

Nov. 14, 2017
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Under a new category of generic ANDAs eligible for priority review, the FDA will prioritize applications likely to be ready for approval shortly after the six months of marketing exclusivity that is awarded to a first-to-file generic drug.

The new category expands the agency’s policy announced earlier this year on expediting applications for drugs with little-to-no competition.

“This way, soon after the 180-day exclusivity period lapses, consumers can have the benefit of brisk competition from multiple other generic entrants. This can improve affordability and access to important drugs,” said FDA Commissioner Scott Gottlieb, describing the move as part of the agency’s drug competition action plan.

Earlier this year, the FDA pledged to prioritize review of ANDAs until at least three generic versions of each particular drug were approved. At the same time, the agency published a list of generic-ready NDAs.

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