Official Approval Action Numbers and More for January and Update of December 2020 Stats

OGD released its official numbers for approval actions, complete response letters and ANDA original receipts for January today, as well as updating metrics for December 2020.  From our unofficial numbers reported for January, we hit the numbers of full approval actions on the nose at 62, but OGD snuck in an additional tentative approval action officially reporting 8 (we only reported 7) see our projections here.  Thus, the total official approval actions for January were 70.  Of the 62 full approval actions, 5 were for first time generic approvals.

OGD issued 157 Complete response letters in January, which is the second lowest in the 4 months of FY 2021.  With a banner month of new ANDA submissions in December of 124, the number of new ANDA submissions dropped to 36 in January, which is also the second lowest monthly ANDA submission in FY 2021.

The December update includes a new first – there were no refuse-to-receive actions taken by OGD in December.  OGD also only acknowledged 31 ANDAs, which is a low for all of FY 2021 thus far.

Of the 63 full approval actions, 10 (or about 16%) were first-cycle approvals and of the 22 tentative approval actions 2 (or 9%) were first-cycle approvals.  Information requests (370) were the highest of the first three months reported for FY2021 and discipline review letters’ issues (168) was in line with last month’s number.

ANDA amendments shot up to 292, almost 100 higher than each of the previous two months this FY.  Changes-Being-Effected supplements dropped significantly to 787 vs about the 960 level seen in the previous 2 months.  DMF reviews hit 90 a number not seen for a while.  This could signify new API entrants into the market or other component suppliers, etc., being called upon by ANDA applicants to support their ANDA filings. Interestingly, controlled correspondences dropped below 300 (280) for the first time since May of 2020 (270).

All of the metrics keep vacillating up and down, so it is hard to get a complete picture of the direction or to suggest any trends occurring from the industry or the FDA.  Perhaps with a few more months of reporting we may see a clear direction for FY 2021.  Stay tuned!