Update on Discrepancy Provided by FDA Regarding April Approval Numbers

In our post from June 10, 2019 (here), we commented on an apparent revision in the number of approved ANDAs from the month of April (a change from 98 to 93).  While scratching our heads about the apparent discrepancy, the FDA’s Kristofer Baumgartner, M.A., Director, Division of Public Education and Outreach, came to the rescue by providing the following explanation:

I just wanted to let you know the change from 98 to 93 final approvals for April between the preliminary and final metrics posting you noted in your blog was just a posting error on the FDA’s part.  The numbers weren’t changed due to reassessment of what was originally included in the count.

Thanks, FDA, for the clarification.  This should make us all feel more comfortable.  I was going to wait until the official approval numbers were posted for May but did not want to delay providing the new information any longer.  I am glad the FDA reads our blog posts, and hope you tell your colleagues that they can sign up for free notification of new posts through our website at www.lachmanconsultants.com and just click on the blog button.  There you will find an option for a (free) subscription.