FDA Generic Approval Data Trends and Analysis for FY 2022

The U.
S.
FDA Office of Generic Drugs (OGD) recently updated its FY 2022 Total Generic User Pay (GDUFA) approval and receipt data
.
The FDA completed a total of 722 in fiscal year 2022 Simplified New Drug Applications (ANDA) were fully approved, 43 more than last year, but less than in previous years and 213 fewer than the record 935 approvals in fiscal 2019
.
raw ANDA has 857 submissions, so this year's submissions again exceeded approvals, and GUDFA has only had more approvals than submissions in 2019 so far
.
GDUFA down Comprehensive data on ANDA's full approval, provisional approval, and submission volume is shown in the chart below:

Let's take a look at some other data:

The OGD Refusal (RTR) 49 ANDA in FY2022 was consistent with the previous two fiscal years, and full response letters also continued to decline with 1,811 letters
.

The number of requests for information (IRs) in FY2022 was 4,370, compared to 4,313 in FY2021, and the number of disciplinary review letters was 2,484, an increase from FY2021 9%
。 The FDA began reporting IR and DRL statistics
based on GDUFA II starting in fiscal year 2018.
Of the four years, the year with the highest number of IRs was FY2018, with a total of issuance 4,452 IRs; The year with the most DRLs was FY2019, with 2,997 issued
messages.

First-round approval rate, OGD began reporting first-round approvals during GDUFA II, with 130 out of 722 full approvals in FY 2022 Full approvals (18%) were first-round approvals, which is roughly the same
as the 17.
8% first-round approval rate in fiscal year 2021.
Whereas, the FDA has committed to working to improve GDUFA III , a metric that needs to improve significantly over the next five-year GDUFA cycle to be successful
.

For Effective Change (CBE) supplemental applications, OGD received 8,426 in FY 2022 and a whopping 9,557 in FY 2021
.
This may indicate support for OGD The workload of the Office of Pharmaceutical Quality (OPQ) for chemical reviews has slowed
.
A total of 1,296 Prior Approved Supplemental Applications (PAS) were received in FY 2022 and 1,351 in FY 2021 servings, slightly reduced
.
For many PAS supplemental applications, more resources are required to review these supplemental applications
.

Finally, for the Controlled Letter (CC) related indicator, 3732 controlled letters were received in FY2022, although compared to 3897 in FY2021 The envelope has decreased slightly, but the amount of controlled functions is still huge and requires considerable resource commitments because controlled functions have target dates
.