August was an even better month than we predicted in our post on September 8th (here). There were actually 98 (instead of 96) full approval actions and 12 tentative approval actions for a total of 110 approval actions. The two (2) approvals missed likely were at the end of the month when we first discovered the computer glitch that was reporting tentative approvals but not full approvals. Anyway, that is good news for OGD.
Of the 98 full approvals, 22 were for first time generics, 23 (23.5%) were for first cycle approvals (that is the highest percentage we have seen in a while) and there were 14 imminent actions issued. As for the 12 tentative approval actions, two (2) (16.7%) were first cycle tentative approvals along with four (4) imminent actions. The imminent actions will likely show up as additional approvals in the official September numbers.
From an analytical perspective, complete response letters, PAS approvals, information requests, and discipline review letters were all WNL (within normal limits). You can see the actual figures themselves here.
Pending ANDAs awaiting FDA action hit the lowest number thus far for FY 2023 at 1545, as did the number of ANDAS awaiting applicant action at 2018. This, in part, shows that the number of approvals increased faster than the number of new ANDA submission received through August 2023. It also could be impacted by the rate of unapproved ANDAs being withdrawn, which is slightly higher than last FY.
OGD received 57 new ANDAs in August, a number a bit lower than what I predicted, since we are approaching the new FY that brings significantly higher ANDA user fees beginning on October 1, 2023. Perhaps the big end of the year rush to submit will be in September. Absent a huge number of ANDA being submitted in September, it does look like approvals will outpace receipt of new ANDAs for the first time in a while. We will have to wait to see once the official numbers are in for FY 2023.
Supplemental submissions continue at a brisk pace with a total of 916 received (775 CBEs and 141 PAS) in August. The numbers of controlled correspondence dropped to just below the 300 level to 284 (monthly average for 11 months is 305).
So now we sit and wait for the end of FY 2023 official statistics, which will also include the 4th quarter summary of approval times of ANDAs. That is always a fun factoid to review. It will likely be early November before we see those figures, but we will be here to provide you with an update as soon as they are available!
