Well, we hit the nail on the head (at least for approval actions in March)! As predicted in our April 5th post (here), OGD issued 48 full approval actions and 13 tentative approval actions for a (low) total of 61 approval actions, and that is exactly what OGD is reporting in its official monthly stats (here).
Of the 48 full approvals, two were for first-time generics and seven (14.6%) were approved in the first cycle. There were also seven imminent actions that will likely translate into full approvals in the April/May statistics. Of the 13 tentative approval actions only one (8%) was approved in the first cycle. In the first six months of the year OGD approved an average of 53 ANDAs per month, which would project out to about 633 ANDA approvals for the full fiscal year. That would be a low since FY 2015 when OGD approved just 492 ANDAs.
OGD hit a low for FY 2024 in the issuance of complete response letters with just 120 issued (previous low for this fiscal year was 131 in November 2023). March saw the highest number of refuse-to-receive letters issued this fiscal year with the Agency issuing five RTR. OGD did acknowledge 51 new ANDAs in the month.
During March, OGD issued 353 information requests (IRs) (192 for original ANDAs and 161 for supplemental applications). The average number of IRs for the first six months of the fiscal year was 360. Interestingly, the 6-month total for original ANDAs was 1036, whereas supplemental IRs was greater at 1128. During March, OGD also issued 178 discipline review letters, in line with previous months. OGD approved 127 PAS supplements during March.
On the receipt side of the house, March saw the submission of 57 new ANDAs and, thus far through the first six months, OGD has officially received an average of 59 ANDAs per month, which would project a full fiscal year of 708 new ANDAs. This would be the lowest by far of the number of original ANDAs received since FY 2015 when 539 were received. Remember that FY 2015 was a one-off year as there were several issues regarding changes in the RTR policy that resulted in OGD issuing 236 RTR letters.
OGD also received 212 amendments for pending applications, of which 69 were classified as major, 78 as minor, and there were 65 unsolicited amendments received. OGD also received 1022 supplements in March (802 CBEs and 220 PASs). Controlled correspondences received dropped below the 300 mark to 260 for March.
There were 1452 ANDAs pending FDA action and 2095 awaiting applicant action. These numbers have been rather steady with slight ups and downs to each.
This being the end of the second quarter, as far as published statistics, OGD has provided median and mean approval times for the second quarter. The mean approval time for full approvals in the second quarter rose from 39.84 to 42.73 months, while median approval times decreased from 26.07 months to 25.66 months. The mean times for tentative approvals dropped from 40.69 months to 39.37 months, and the median tentative approval times took a big drop from 29.96 to 23.53 in the second quarter. As OGD has previously explained, the mean approval times will be longer than the median times because of the older applications lingering on in the review queue undergoing multiple review cycles.
While we have highlighted some of the most significant statistics, the full set of the first two quarter statistical reports for FY 2024 can be found at the link provided at the end of the first paragraph of this post.
