Well I don’t know whether it was my continued questioning of the whereabouts of the last three months’ report figures, although I highly doubt it, or the rehiring of some of those policy people previously RIFed that finally gave the OGD enough bandwidth to get to the many things on its plate, with this report being one of them.
Having said that, let’s look at the some of the numbers from the report, which can be found here. There are three months of data so I may be a bit brief in the discussion below but I’ll try to comment where appropriate.
Approvals of original ANDAs in February, March, and April were 53, 54, and 62, respectively. Through the end of April, the OGD had approved 419 new ANDAs. Thus, the average number of ANDAs is just under sixty per month. Projecting that out for twelve months, we can expect the OGD to approve about 718 ANDAs in FY 2025, which would be higher than FY 2024’s 694. First-time generic approvals during those three months were 6, 10, and 7, respectively. First-cycle approvals were 6 (11%), 9 (16.7%), and 19 (30%), respectively. This tracks as an increase in each of the three months, with April having perhaps the highest percentage of first-cycle approvals we have seen during the GDUFA program! We will obviously need more data to determine whether this is a trend or just a one-time occurrence. As an aside, imminent actions (applications for which the OGD deliberately extended the goal dates to take them to final approval) for the three months were 7, 8, and 4.
In terms of tentative approval actions, February, March, and April came in at 16, 22, and 16, with first-cycle approvals at 2, 6, and 4, respectively.
In addition, information requests soared to a high of 428 in April, the highest we have seen this fiscal year. The breakdown of information requests is 219 issued to original applications and 209 for supplemental applications. February and March were also on the high end for the fiscal year at 377 and 407, respectively. Discipline review letters were at 105, the second lowest for fiscal year, which may be due to the high number of first-cycle approvals.
On the incoming side of ledger, in February, March (the end of India’s FY), and April, the OGD received 34, 84, and 52 new ANDAs, respectively. The total number of ANDAs received so far this fiscal year is 321. Last fiscal year at this time, the OGD had received 419 new ANDAs. This is bad news, my friends, as projections at this time for the full twelve months of FY 2025 indicate that the OGD will likely receive only about 550 new ANDAs compared to FY 2024 receipts of 740. Yikes! We would need some big submission months ahead to even get close to that figure!
The OGD also received 171, 185, and 170 amendments in February, March, and April, respectively, which is in line with the rest of FY 2025 submissions. The new big-ticket item appears to be supplemental submissions, with the OGD receiving 824, 954, and 1,083, respectively, during the period from February to April. Please see the full report for a breakout of CBE and PAS supplements. The March and April figures are the two highest for supplemental submissions this fiscal year.
Controlled correspondences are also keeping up, with numbers in the 300+ range; April had the largest number of CCs, 362, submitted for FY 2025. I guess with a considerable number of seasoned staff left at the OGD, folks are making sure that any issue that’s not clear cut is papered by the FDA’s response to the CCs.
The number of ANDAs pending FDA action, a measure of the OGD’s workload in-house, was 1,368 in February, 1,371 in March, and a new low since this metric has been reported on the GDUFA scene of 1,363 in April. This is reflective, in part, of the low number of ANDAs being submitted. ANDAs awaiting applicant action are staying about the same with the three months of new reported data showing 1,935, 1,933, and 1,948, respectively, in the industry’s court.
Finally, the second quarter statistical results have been published for mean and median approval times. As noted in the chart below, approval times for each metric have fallen, with the largest drop seen in the mean approval and tentative approval times.
This is good news! Let’s see whether this trend continues in the third quarter.
Well, that’s all for now as far as the Generic Drugs Monthly Statistical Report goes. Please see the report for the other metrics not called out in this post by clicking the link in the second paragraph above.
