New Report, Same Problem? I Am So Confused!

Well ANDA fans, we have been trying to track ANDA approvals and tentative approvals during the month and now the FDA has given us another tool called the FDA Approved Drug Products “All Approvals” report (here) which can be run for a specific month.  In addition, the FDA Approved Drug Products daily listing (here) can now be run for a 7- or 14-day period.  Quite interestingly, the format of the report has changed back and forth in the last couple of days and now there is an option for an Xcel spreadsheet on the “All Approvals” report, which makes searching for original approvals a bit easier.  Thus, the reports have been upgraded to permit some additional searching capabilities and ease of evaluation.

That is the good news.  The bad news is that the numbers still don’t seem to add up!  We will check the tally from the new report against the official approval numbers on the Activity Report of the Generic Drug Program FY 2017, when it releases in the next few days and see if a count using the “All Approvals” report matches the numbers OGD reports.  If it does, then that will eliminate the daily tracking we have been meticulously attempting.

Anyway, for you ANDA nerds like me, it looks like OGD will be approving somewhere between 56-61 ANDAs and somewhere in the neighborhood of 9 tentative approvals.  Still not the jump in approval actions industry has been hoping for, but about the same as we have been seeing monthly this fiscal year.  Who knows, maybe there will be more approvals than reported.  If so, then reliance on the new “All Approvals” report will still not be able to rely heavily on the FDA computer-generated reports mentioned above and require us to wait for the OGD official numbers to issue.

Please let me know your take on the usefulness of these reports, their formats, and how you feel about the current rate of ANDA approval action.  It will be interesting too if the number of ANDA submissions again outpaces the number of approval actions. I can be reached at r.pollock@lachmanconsultants.com and will be interested in your views.