June 2023 Official Generic Drug Statistics Including Mean and Median Approval Times Published

The statistical report (here) provides full official statistics through the third quarter Fiscal Year (FY) 2023.  There is some good news when looking at mean and median approval time that we will discuss later. But for now, let’s look at some of the more important FDA approval actions for June 2023.

OGD approved 76 new ANDAs in June.  Of the 76, 8 were first time generic approvals and 13 (17%) were first cycle approvals.  For some reason, the percentage of first cycle approvals fluctuates but can’t seem to consistently stay above 20%. In addition, OGD issued 12 tentative approval actions and, of that, only 1 (8%) were first cycle approvals. OGD also reported there were 5 imminent approval actions and 1 imminent tentative approval actions that will likely translate into approvals early in August.

At the current rate, the straight-line projections for approvals for the full FY should come in around 761, which will beat last FY’s total of 722.

Other important statistics include the issuance of complete response letters (CRLs) of which OGD issued 120 in in June which is close to the monthly average of 128.  OGD issued 69 acknowledgement letters and only refused-to-receive 4 ANDAs upon submission. Information requests, discipline review letters, and information requests were both the second highest totals for this FY thus far at 342 and 225, respectively.

ANDAs pending Agency action stayed just below 1600 at 1593, while ANDA awaiting sponsor action stood at 2060. New ANDA submissions for the month totaled 55 and projections for the full FY 2023 at the current rate would likely be about 756, meaning that receipts of new ANDAs will likely outpace ANDA approvals again.

OGD received a total of 229 amendments broken down by 78 major, 49 minor, and 102 (a high for this FY to date) unsolicited amendments. The Agency also received 1012 supplements in June (866 changes bring effective [CBE] and 146 prior approval supplements). While CBEs dropped off from last month’s high of 986, it still represents the second highest of the FY and represents a large workload addition to the OGD and OPQ staff. Controlled correspondence submission stood at 313 with a monthly average thus far this FY of 305.

The end of the quarter means an Agency calculation of Mean and Median approval times for both Approvals and tentative approval actions.

As you can see, the numbers look pretty good this quarter as all of the metrics went down. You can view all of the official monthly statistics at the link at the beginning of this post.