When we looked at the mid-month February approvals back on February 22 (here), we projected that February might be a slim month for full approvals and we were right. OGD issued a total of 46 approval actions in February, the lowest total for a month thus far this fiscal year (FY). Of the 46 full approval actions, five (5) were for first time generic approvals and six (6) (13%) were for first cycle approvals. There were also six (6) imminent approval actions issued. At the same time, OGD issued 21 tentative approval (TA) actions, for a total of 67 approval actions for both tentative and full approval actions. None of the TAs were approved in the first cycle. So, while the number of ANDA full approvals was the lowest, the total approval actions actually beat the low for the FY of 59 that occurred in December 2022.
You can see all of the metrics by viewing the Generic Drugs Program Monthly and Quarterly Activities Report (here) but I will provide the highlights as I see them for you.
Complete response letters can’t seem to get out of the 140’s, with this month’s total at 141. Hard to tell if that is good or bad news because OGD can go beyond its goal date in an effort to reach final approval and that it what the imminent action is all about.
Refuse-to-receive letters dropped back down to three (3) in February from the five (5) issued in each of the last two months (good work, industry). OGD did acknowledge 76 new ANDAs in February, but only received 38 new ANDAs, which is the second lowest for any of the five months thus far in FY 2023 (October saw only 34 new ANDAs). In the first five months of this FY, there have been 298 ANDAs received, which (at the current monthly rate) would project to 715 ANDA for the full FY, or about 142 less than last FY’s total of 857 new ANDAs received. We may be singing “where have all the ANDAs gone, long time passing” if this holds true for the rest of the year. We will project ANDA approvals after the 6-month official totals are in for FY 2023. Remember, March looks like a big month (see here). I can’t wait to report that number!
While information requests still hover in the low 300s, the discipline review letters issued in February were the lowest of the FY at 146 and show a decreasing trend over the last three months. Pending ANDAs awaiting FDA action dropped a bit to 1609 (a number that fluctuates due to new submissions and amendments submitted by industry), while the number of ANDA awaiting applicant action rose slightly over the last three months to 2134 (broken down to 485 outstanding tentative approval letters and 1649 complete response letters awaiting industry response.
Changes being effected supplement submissions hit the highest monthly total thus far this FY at 623 (monthly average of 588 over the first five months). Prior approval supplements came in at 104, which is a bit lower than the 5-month average of 115 but in the ballpark.
There are lots of other metrics available for review, so have a go at it if you so choose at the link in the second paragraph of this post. Enjoy!