Well, not only were we close, but we also hit the approval numbers for July on the head with 46 approvals and nine tentative approvals. While we reported 47 approval actions in our August 5, 2021 post (here), there was one July approval for a product with two strengths that are separately reported as approval actions in the daily approvals list, but are collapsed into a single approval in the Generic Drugs Program Activities Report – Monthly Performance (here), resulting in the discrepancy in our prediction versus the reported numbers. Of the 46 approvals, three were for first-time generic products. As far as tentative approvals go, there were 9, which brings the total number of approval actions to 55, the lowest number of approvals and tentative approvals thus far this FY.
The number of complete response letters (CRLs) bounced up to 169, the second highest for FY 2021 behind the 183 issued in February 2021. The monthly average of CRLs thus far this FY is 154.2, compared to 167.5 in FY 2020 and 192.5 per month in FY 2019 and 220.7 in FY 2018. The OGD received 45 new ANDAs in July, for an average of 62.3 per month. While we know, historically, that December numbers are likely to be higher, right now the estimated number of ANDAs for the full FY, based on the ten-month average, will be about 748, well below the 865 received in FY 2019.
Numbers, numbers – numbers sometimes seem like the only things that matters – but what else is there for the industry to rely upon as the costs for conducting the studies necessary to support the filing of an ANDA, the fees to stay in the game, and other costs associated with maintaining a business keep going up while the downward pressure on drug prices continues to slice into profit margins?