For the first time since GDUFA’s beginning, the number of ANDA approval actions exceeded the number of ANDAs received in a given FY (935 approvals vs 909 new ANDA receipts). In addition, OGD smashed the FY approval record with the 935 approval actions by 154 (or 16.5%) more than the previous record of 781 in FY 2018.  OGD also broke the record for the number of tentative approval actions as well with 236 which is 46 (or 19.5%) higher than the previous record recorded of 190, also set in FY 2018. The monthly approval action average for the full 2019 FY was 77.9 with a monthly receipt rate 75.6

For the first 8 months of FY 2019, OGD was averaging over 88 ANDA approval actions a month and, based on that figure, at the time, we projected that OGD could reach 1060 approval actions; however, the last 4 months of FY 2019 saw an average of just under 57 per month which dropped the yearly average down. June was the month with the lowest approvals with 45 actions and September was the next lowest with 55.  The FY year started out with a gangbuster month in October 2018 when OGD reported 110 approval actions.  Not sure why the slowdown occurred in the last quarter, it could have just been one of those things – that is, there was no particular reason.

Other September metrics released on October 16th include the number of complete response letters which tied December 2018 for a fiscal year low of 144.  Could the increase in approval and the decrease in CRLs point to the FDA working through the GDUFA date to get the application to approval?

Sorry that I can’t give you an accurate picture of the October approval and tentative approval actions because of the problem associated with posting those on the FDA public approval sites.  We will keep as good of an eye on things as we can for you, as we know how important this information is for the industry.  Figures reported above were taken from the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance which can be found here.

OGD did a heck of a job this year and hopefully it will be able to break another record next year. It should because they have the highest number (>2000) of FTEs (full time equivalents), in the history of the program (see story by reported in the Pink Sheet by Derrick Gingery, entitled US FDA’s GDUFA-Related FTEs Increase … Except In CBER (here; paid subscription required))