Although we were caught off guard by a slightly early update to the July metrics which preceded Official August approval and receipt numbers, we are happy to present them to you at this time.
OGD issued 4 refuse-to-receive (RTR) actions and all four were for standard ANDAs. The Agency acknowledged (filed or received, whatever you choose to call the action) 56 new ANDAs in July.
Of the 69 full approval actions issued in July 2020, fifteen (or 21.7%) were first cycle approval actions but none of the 13 tentative approval (TA) actions represented first cycle TAs.
Complete response letters popped up a bit to 160 compared to 124 in June and were a bit below the 10-month average of 171.6. Information requests were slightly above the 10-month average of 350.9 at 387, and discipline review letters fell from June’s 335 to 210 but this is very much in line with the 10-month average of 213.1.
As far as supplemental applications go, they were about 100 less than June’s 951 at 858 but also in line with the 10-month average of 793. Prior Approval Supplements hit a FY 2020 high with 119 being submitted to OGD. Another high-water mark was a wave of 355 controlled correspondence (CC) submissions which represents a record number in any one month under GDUFA I and II thus far. Either things are getting more complex or firms are becoming more afraid to guess and/or want greater assurance that the position they are taking is in line with FDA expectations. The 10-month average for CCs for FY 2020 is reported at just under 298.
We will update the official August receipts, approvals, and tentative approval actions as well as complete response letters once they are posted by OGD. The Generic Drugs Program Activities Report – Monthly Performance Fiscal Year 2020 which formed the basis of these metrics, can be accessed here.