Official June ANDA Approval Actions, Receipts, CRLs, and Update to May Stats

Well, there were some hidden tentative approval actions that must have been posted fairly late after June was over as the OGD official numbers released for June show OGD had 14 Tentative Approval (TA) actions (we reported just 5 in our post on July 6 [here]). (However, when looking at the FDA all approvals list for June 2020, only 6 TAs show up.  We have notified OGD of the discrepancy.) OGD also reported 73 full approval actions (we reported 74, so perhaps one of those was mistakenly reported as a full approval but should have been a TA action) for a total of 87 approval actions for the month of June. While 73 is the record high for FY 2020 for full approval actions, the total of 87 approval actions ties the month’s total approvals actions from April 2020. 5 of the full approval actions represent first time ANDA approvals.

Complete response letters (CRLs) fell to a low of 124 in June; the previous low this FY was last month at 149. The 124 CRLs represent the lowest number issued since July 2017, when only 82 CRLs were issued.  OGD received 59 new ANDAs in June.

With a close to the 3^rd quarter of FY 2020 behind us, estimates for full approvals for the year now stands at 740 and receipts of new ANDAs is at 884, at the current rates.

The May statistic update shows that OGD refused-to-receive 4 ANDAs (1 standard for 3 priority applications) in May and acknowledged 77 new ANDAs. Of the 63 full approval actions reported previously, 14 were approved in the first cycle (22%) and, of the 15 Tentative Approval actions in May, none represented first cycle approvals (don’t need a calculator for that).

Information requests hit  2^nd place at 414 behind March’s high of 419.  Most of the other statistics looks about average except for prior approval supplements that hit a FY high of 110.

All of these statistics can be reviewed in the  Generic Drugs Program Activities Report – Monthly Performance – Fiscal Year 2020 report (here).  All in all not bad month for OGD and the high tying month of approval actions for June are, I am sure, somewhat pleasing to industry.