The Office of Generic Drugs (OGD) posted its official numbers for approval actions, receipts and complete response letters in the last hour.  The figures, from the Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance (here) show that OGD broke the old record of 763 approvals achieved in FY 2017 by 18 ANDAs, approving a total of 781 in FY 2018.   September approval actions were reported at 62 full approvals and 13 tentative approvals (190 for the full FY which also is a new GDUFA record). All-in-all, OGD had a total of 971 approval actions (also a new record) in 2018. This is a good sign which shows movement in a positive direction as we close out the first FY of GDUFA II.

On the receipt side of the ledger, OGD received 99 ANDAs in September, with a total of 1044 new ANDAs total in FY 2018. This is the third highest number of new ANDA submissions since the beginning of GDUFA, with FY 2014 having the highest at 1473, and FY 2017 logging in the second highest number of original submissions at 1306.  The low was in FY 2015 at 539.

The submission numbers seem to bounce around from year to year and it is very difficult to see any trend developing.  What we do see is a lot of new company names on the daily approvals lists. This is reminiscent of the early years of Hatch-Waxman when several new companies sprung up to try to take advantage of this lucrative market.  We also notice quite a few new Chinese firms gaining approvals.  New firms start off with 1 or 2 ANDAs a year then gear up from there.  From what I see, I doubt that we will see a significant drop in ANDA submissions over the next few year and we may even see new record numbers of submissions if the smaller and new companies experience early success.

Quite interestingly, in September, OGD issued the lowest number of complete response letters (133) for all of FY 2018.  FY 2019 appears to be getting off to a good start for approvals as well, with 22 reported so far through October 9th.

We will update you on the rest of the final FY 2018 numbers when they are posted by OGD.