Happy July 9th! Hope you had a great Fourth of July weekend, but now it’s time to get back to business. The OGD seems to have squeaked by its lowest month totals of approval actions this FY (for May) as it appears to have recorded sixty total-approval actions for June, at least through the July 7th reporting on its All Approvals site (here). Total full-approval actions reported thus far were forty‑six (tying the May number of actions) but the OGD issued fourteen tentative-approval actions, two more than the May number of twelve.
Once the official numbers come out, we will provide a projected total for FY 2021, which ends in three months. It does not look like the OGD will break any record highs this year as most of the workload metrics have seen declines, including receipt of original ANDAs.
This certainly does not mean that the OGD and OPQ have not been busy as there have been a number of webinars, policy actions, and bioequivalence guidances issued this year. There have also been updates on the number of applications approved through the OGD’s Competitive Generic Therapy as well as reports on first generic approvals. There are a lot of additional activities that go on behind the curtain that we really do not see and utilize valuable resources within the OGD, like the negotiations for GDUFA III. We will soon be seeing the new commitment letter, as well as the new GDUFA III fees for FY 2022. So, hold onto your hats and we will be back to you shortly with the official numbers and much, much more!
