The FDA posted its final approvals and receipts numbers for FY 2017 today.  We thought there might be a blip in receipts due to firms trying to beat the GDUFA II fee clock which took effect on October 1, 2017, and we were right.  OGD received a whopping 202 ANDAs in September.  This was not a record month in FY 2017, as in December 2016 OGD received 235 ANDAs and in March of 2017 they received 197 ANDAs.  For the full fiscal year OGD received 1292 ANDA, an average of 107 per month. The ANDA record year for receipts was FY 2014 when OGD received 1473 ANDAs.  FY 2017 is recorded as the second highest month for ANDA receipts in the history of the program.  I am certain that many more ANDAs would have been submitted if the industry had an earlier warning on the increase in ANDA Fees ($171,823 per ANDA in FY 2018 vs $70,480 in FY 2017).  But with only a months’ warning, it is clear that firms tried to clear the decks the best they could.

The good news is that OGD approved a record number of ANDAs in FY 2017, totaling 763 or a monthly average of 63 ANDAs.  The FY 2017 record is 112 higher than the previous high (in FY 2016) of 651.

September saw another month with 155 complete response letters (CRLs) and, as time has shown us, when CRLs decrease, the number of approvals tend to increase.  Because this is the second month in a row of a high number of CRLs, we don’t believe this will bode well for approval numbers in early FY 2018.

To see the numbers posted for FY 2017 from the FDA, click here. We will be keeping a close eye on the developments as we see them in FY 2018 so tune in frequently for our take on what we see.