Well, with the final FY 2022 totals now in for some of the OGD’s most important metrics, let’s see how this fiscal year stacks up other GDUFA years. But first, September saw sixty-eight full-approval actions of which nine were for first-time generics and only nine tentative-approval actions along with ninety-eight new ANDAs and 141 Complete Response Letters.
In FY 2022, the OGD fully approved 722 ANDAs, which is forty-three more than last FY’s total of 669. The OGD issued 183 tentative-approval actions, up from 157 last fiscal year. As far as receipts of new ANDAs, the OGD reported 857 in FY 2022 so, once again, receipts outpaced approvals, this year by 135. There has only been one year where approvals outpaced receipts and that was in FY 2019 when there twenty-six more approvals than receipts.
A complete chart of GUDFA II full approvals and receipts appear below.
| Fiscal Year | Full Approvals | Number of ANDA Receipts |
| 2022 | 722 | 857 |
| 2021 | 679 | 809 |
| 2020 | 737 | 865 |
| 2019 | 935 | 909 |
| 2018 | 781 | 1044* |
* Highest number of FY receipts since the beginning of GDUFA was 2014
when there were 1,473 new ANDAs received.
The average number of approvals for GDUFA II years was about 770.8/year and average receipts over the five-year GDUFA II cycle were 896.8/year. We will have more yearly statistics for you to chew on once the OGD provides a full update to the September numbers.
