May Monthly ANDA Approval Information – But the Wait is On!

Information on the FDA’s Monthly Approval Report (here)  is usually not complete.  Typically, there may be up to a 5-10% discrepancy (lower than actual) in the numbers of Approvals and Tentative Approvals reported.  The discrepancy improves over time but seldom do the numbers actually match the reported number of approval actions on the Activities Report of the Generic Drug Program for the same month.  Unfortunately, the Activities Report of the Generic Drug Program is not updated until at least mid-month (here).

In the past, we have obtained the public approval numbers (and new original ANDA receipt numbers) ahead of the report hopefully to get the information out to our industry colleagues sooner.  However, that is no longer possible.  What we can tell you at this time is that the FDA Monthly Approval Report shows 47 full ANDA Approvals and 16 Tentative Approvals.  When the Generic Drug Activity Report updates, we will report on the actual numbers for the month of May.  These numbers are likely lower than actual OGD approval actions – but as these numbers stand, it will be more to the lower end of monthly approval activity for this fiscal year.  The good news is that we expect the numbers to be higher, but how much so we won’t know for a while.

Recognizing that the FDA has to assure that the numbers are correct before publically releasing them, we understand that position.  However, what we don’t understand is how the FDA Monthly Approvals report can be so off.  If we could rely on that database, we would not need to ask FDA or wait for accurate approval numbers.  But we will bite our nails a little shorter  for a longer time each month to see how OGD is doing.