OGD released its official approval and receipt numbers on Wednesday afternoon and, as was predicted (almost) in our previous blog (here), it was somewhat disappointing. We missed the approval actions by one. OGD actually issued 45 approval actions (we found only 44), and they issued 17 (as predicted) tentative approval actions for a total of 62 approval actions for June 2019. If we straight line approvals for the full year, OGD can theoretically get to 1004 for FY 2019 (still a record), but if the numbers continue in this trend over the last three months of the FY, OGD might wind up well below the 1000 mark.
The number of Complete Response Letters (CRLs) dropped to 180 for June (if you recall, we speculated that the larger number of CRLs in May , might be contributing to why approvals were down. Well, that is clearly not the case!) Could it be vacations? We certainly can’t tell because we do not get the background on actions, only the numbers and not a discussion of the issues involved in generating the actions.
The other somewhat shocking number is the number of new ANDA receipts for June (48) – the previous low was in FY 2016 when, in January 2016, OGD received only 40 ANDAs. If we straight line approvals for the full fiscal year, OGD can be expected to receive 928 new ANDAs in FY 2019. This is considerably lower than the last two FY (1306 and 1044 in 2017 and 2018 respectively).
So, is this representative of the summer slowdown? What will the last three months of this FY look like? We will keep you well informed.