FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Releases FY 2018 Numbers for Fast-Tracked ANDA Generics

Nov. 12, 2018
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The FDA logged a steadily increasing number of fast-tracked ANDAs in fiscal year 2018, according to the agency’s first annual report mandated by the FDA Reauthorization Act.

The fiscal year — beginning Oct. 1, 2017 — got off to a slow start with just two ANDAs under priority review awaiting agency action in the first quarter. But the number steadily climbed, reaching six ANDAs in the second quarter, 16 in the third, and peaking at 29 in the fourth quarter — when the agency approved the first fast-tracked ANDA.

ANDAs that received a competitive generic therapy (CGT) designation saw a similar upward trend, with three awaiting FDA action in the first quarter, rising to 16 in the second quarter, 33 in the third, and closing out the fourth quarter at 45.

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