December Generic Approvals Flatline Continues

With the first quarter of FY 2020 in the rearview mirror, a review of the FDA’s All Approvals list (here) and the FDA’s Recent New and Generic Approvals list (here) looks like the new monthly normal for full approval actions will likely be close to sixty per month with about an additional ten tentative approval actions.  So far, in December, the FDA has posted fifty-nine full approval action and ten tentative approval actions (same as November).  Of course, the December 2019 numbers are not yet official, so we might break the tie with the November 2019 numbers if additional stragglers are reported over the next couple of days.

Once the official numbers are posted for December, we will provide the first projection for the full FY 2020 based on the first quarter official figures.  We also must note that December approvals are not usually the highest monthly numbers we see for any FY due to vacations around the holidays, but the emerging pattern in the first quarter is also not typical.  October and November are usually significantly higher than activity in December.

We will have to wait a few more months to see whether this is indeed the new normal or just a temporary phenomenon.  Stay tuned and happy New Year to you all.  How about them Ducks (sorry if you did not watch the game)!