As we hoped in our post here, the unofficial approval numbers for December were pretty good. As of postings on the FDA’s All Approvals list as of January 7, 2021 (here), OGD posted 63 full approval actions and 20 tentative approval actions for a total of 83, up from the November 76 total approval actions. While not a high by any means, it is movement in the right direction to look like average numbers from the previous year.
We will report the official approval numbers for December when OGD posts them sometime in mid-January. We will also do some estimate and projections for the full FY 2021 approvals. The first quarter is usually a good predictor for the rest of the year. With new ANDA submissions down significantly in the first two months of FY 2021, we anticipate that 10 months from now we may see lower approval numbers unless there is a big change in the next month or two.
Welcome to the New Year everyone and stay tuned for this year’s blog party!