As noted in a previous blog post (here), I did not expect ANDA approvals to reach anywhere near normal levels for a few months. Since that post, OGD has posted a few more approval actions; the official numbers for February were reported today at 32 full approvals and 5 tentative approvals (as opposed to 29 and 4, respectively, as reported earlier).
In addition, FDA reported receiving 55 ANDAs in February and issuing 184 complete response letters (CRLs). Interestingly, the number of CRLs is the lowest by far this fiscal year with the previous four months’ figures beginning October 2017 reported as 325, 240, 242, and 307 respectively. We assume that many of those CRLs may have dealt with the elemental impurities issue.
Anyway, with the caveat of potentially returning to more normal approval numbers later this year, if we take the first 5 months of approval and receipt data and straight-line projections for the year, at this point in time, expect about 734 ANDA approvals and 941 ANDA receipts in FY 2018. The approval numbers (even with the current slowdown) appear to be close to last year’s record number of approvals, so there is hope there, and, if the receipt trend continues, OGD should receive about 350 fewer than the 1306 ANDA received in FY 2017.
According to the updated January statistics, there were only 11 refuse-to-receive (RTR) letters issued that month. Six were for standard review applications received under GDUFA II, three were for GDUFA II priority applications, and two were for GDUFA I holdover applications. OGD also reported issuing 51 acknowledgement letters in February. Also of interest was the fact that of the 25 ANDAs approved last month, 11 were reported as first-cycle approvals and 1 of the 6 tentative approvals was a first-cycle approval. We do not know what cohort years these ANDAs were from.
There were 139 ANDA amendments submitted during January, where 58 were classified as major while 80 were classified as minor. There were also 8 pre-submission facility correspondence received by OGD in February, which is the highest number since the process was instituted.
On the supplement side of the house, numbers for CBEs dropped to the lowest number for the FY at 453 (highest was 657 in November) and PAS supplements for the month were in line with 54 being submitted with 2 receiving RTR letters.
Controlled correspondences totaled 238, which is in line with other months this FY. It continues a trend for sponsors to ask more questions as GDUFA I wound down and continues under GDUFA II.
A complete view of the updated OGD statistics can be found here.