It seems unbelievable that we are now halfway through FY 2023 already. (Well, the stats are halfway through the year, even though we are in month eight (8) of the FY).  Time really DOES go fast when you are having fun! And now with six (6) months of data, we can provide some trends and make some reasonable predictions for full year approvals and receipts and other key metrics. But first- let’s look at March 2023 figures.

In our April 6th post (here) regarding the unofficial approval numbers for March, we hinted that the month would be well above average and it was- OGD wound up with 96 full approval action and 21 tentative approval actions for a total of 117 approval actions for the month.  Not a record breaker for GDUFA. but thus far the record holder for FY 2023.

Of the 96 approvals, four (4) were for first time generics and 16 (16.7%) were for first cycle approvals. Of the 21 tentative approval actions, three (3) (14.3%) were first cycle approvals.  The percent of first cycle approvals clearly fluctuates from month to month but we keep hoping to see those numbers up closer to or over 20%. OGD also issued the most complete response letters (161) in March, the highest so far this FY.

Refuse-to-Receive letters remained low at four (4) for the month and Acknowledgement letters totaled 50. Prior Approval Supplements hit a high for the FY at 159 (previous high for the FY year was 117 in October 2022). Information Requests and Discipline Review Letters also hit highs for the FY with 385 and 297 respectively.

ANDAs Pending Agency Action dropped back below 1600 to 1586, with the drop fueled by the large number of full approvals in March which got those applications off the OGD books. At the end of March, there were 2135 ANDAs out with firms awaiting their response, representing 484 tentative approvals and 1651 complete response letters.

It was also a big month for ANDA receipts with OGD swamped with 112 new ANDA submissions (the highest this FY with only one other month, December, having over 100 ANDAs). Remember that March is the end of the FY for India, and that almost always results in many ANDA submissions to FDA during that month.

OGD also received 255 amendments in March, the most for the FY to date.  The big increase in submissions, however, was reserved for supplements where a total of 921 were received (almost 200 more than any other month this FY (OGD received 757 CBE supplements and 164 PASs). While the 757 CBE supplements was the highest this year, it is not a record. As early as May of FY 2021 OGD received 1018 CBE supplements. For PAS supplements, you need to go all the way back to April of 2018 to see a higher number of PAS submissions when 200 were received.  There was also an uptick in the number of controlled correspondences submitted to 378, another high for this FY.

So, we can see that March was a big month for actions but also a big month for industry submissions.  Lots more metrics to look at and the full report can be reviewed here.

But wait! Because March is the official end of the second quarter for FY 2023, the report also provides mean and median approval times for original and tentatively approvals.  This quarter does not look as rosy as the first quarter (see chart below).

Approval Times by Quarter Q1 FY2023 (Oct-Dec 2022)* Q2 FY2023 (Jan-Mar 2023)*
Quarterly Mean Approval Times 28.82 38.11
Quarterly Median Approval Times 20.6 23.45
Quarterly Mean Tentative Approval Times 25.32 39.88
Quarterly Median Tentative Approval Times 20.31 36.76

*-Times are in months

While on its face it looks bad, these times are greatly impacted by the submission cohort year of the ANDAs for which action was taken during the period.