November was a good month for full approvals, with a total of 61 issued. There were 6 tentative approvals issued for the month. While this is a bit of a fall off from the previous few months, the numbers are consistent with an even keel on approvals. The hopeful goal for now is to begin to have the industry response to the many Complete Response Letters, information requests and Easily Correctible Deficiency letters issued by OGD turn into approvals.
As Dr. Uhl mentioned at the GPhA Fall Technical Workshop a few weeks ago, “there will be good months and bad months.” This looks like an average month. With GDUFA II negotiations underway, average months may not be what the generic drug industry is looking for.
With two months in the books on FY 2016, it is still too early in the year to determine where the final approval numbers will be at the end of the year, but needless to say, if even the average months keep up, OGD will be likely approving well over 500 ANDAs this year.
We still see supplements coming into the Agency at a very high rate. The number of CBE and CBE-30 supplements are averaging over 600 per month and Prior Approval Supplements are still around 40 a month. What is also interesting is that the Generic Drug Activity Report for FY 2016 (here) is reporting on fewer metrics than the previous reports. Not sure why that is, but the amendment section has been entirely removed. We also note that the FY 2015 report was last updated in March 2015. It is not known if those figures will be available at a later date or if the new format is the only data reporting we can expect for the future.
Albeit the new reporting format is a bit less transparent, it was not always clear what the old reporting data really meant. Let’s see what happens with the report, as the FY moves forward.