April 2019 Approval Actions, Receipts, and Complete Responses Posted

Today, FDA posted the official ANDA approval actions and receipts for April 2019.  While the All Approval list reported 93 full ANDA approval actions and 15 tentative approval actions for ANDAs, when we wrote our first blog estimating the approval actions for April on May 3rd  (here) ,   the official FDA numbers for April reported for approval actions was 98 and tentative approval actions was 18, for a total of 116 (see post here).

So far for FY 2019, FDA has reported 630 full approval actions which, at this rate, would translate to 1080 approval actions for FY 2019.  Receipts of new ANDAs in April was 70, representing the 2nd lowest month for approvals this FY. In the first 7 months of FY 2019, OGD received 582 new ANDAs and (using a straight-line estimate) this would translate to 998 for the full FY.

Again, since the FDA added a footnote to its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance, we are not sure how the approval actions or tentative approval action numbers relate to the number of actual ANDAs represented by those numbers.  To refresh your memory, the new footnote, added in early April stated:

FY19 Approval and Tentative Approval counts were updated in April 2019 to better reflect program output by capturing all approval actions on original applications, including split approvals (final approvals of certain strengths in an ANDA at the same time that certain other strengths are tentatively approved) and subsequent tentative approvals of applications that have previously been tentatively approved.

The FDA also issued 208 complete response letters in April, which is slightly above the average of 190 per month reported so far this FY.

We will update you once OGD updates the other metrics for the report.