22 ANDA Approvals in January – Or So We Think!

Well, it’s February 4, 2015 and the “Drug Approvals” page on the FDA website appears to have been updated to include ANDA approvals through January 30 (search on Original Abbreviated New Drug Applications (ANDAs) by Month (here). The FDA database lists 22 ANDAs approved in January, but remember that 9 of the 22 were for Valsartan after the expiration of an exclusive marketing period.  This is substantially under the average of about 34 approvals per month seen in the last two fiscal years (FY), as well as the first three months of FY 2015.

With monthly ANDA receipts of about 38/month in the first quarter of 2015, if these average numbers continue, there will continue to be an excess of receipts over approvals, which means the backlog will continue to grow.  Now, of course, we are in (what we hope) is the beginning of the turning point in OGD productivity at least with regards to approvals, but we still are waiting to turn the corner from the numbers that are being reported.  Also remember that the average monthly number of Complete Response Letters (CRLs) is only 71 per month so far in 2015 (for the first quarter) – that number is down from averages of 104 and 105 per month respectively, in FY 2013 and 2014.

These two specific metrics, original ANDA approvals and receipts, are clearly the biggest and best indicators of OGD’s progress and are of most interest to industry. However,  we have not seen any data on supplements (incoming, CRLs or approvals) so far this FY, so the total picture of the OGD workload is and will be somewhat obfuscated until the full activity report data is reported and back on line.

While I do not like to spend so much time looking at these numbers and casting a negative twist on them, someone has to keep an eye on them and report what we are seeing.  Who better than someone with an FDA and an industry perspective and someone who has lived these numbers since 1984?  So, it appears that my time spent watching these numbers will continue, at least for the foreseeable future.  If you see something in these numbers that I have not seen or if you have a different take on them, I would be interested to hear from you.  Please let me know at r.pollock@lachmanconsultants.com