With just 6 days until Halloween, what does the prospect for Trick or Treat look like in the ANDA approval candy basket? So far, the reporting of approval actions looks like treats will be in the bag. As of approval actions reported through October 22, 2021 OGD has issued 50 full approval actions and 6 tentative approval actions.
This early peek at the numbers indicated OGD’s total approval actions for the month will most likely be about 60 and may be approaching 70+. With FY 2021 average approval actions per month at 61.4, it looks like we will be opening the new FY on a strong note. There were 65 Approval actions for October 2020 with 57 full approval actions and 8 tentative approval actions. We know that such month-to-month comparisons are not very meaningful because we can expect variations by month, but it gives some assurance that OGD may at least be opening the new FY on a higher note than last year.
You can find the approval number in the FDA all approval list here and at least for October we can be assured it will be a Boo and not a Boo Hoo!