As Lester Holt says prior to the closing segment on NBC World News, “There’s good news tonight” – at least in terms of ANDA approval times. In its first quarterly report for FY 2023 all of the approval metrics are under 30 months for the first time that I can remember. (see chart below). This is a new milestone for OGD!
|Approval times By Quarter||Q1 (Oct – Dec 2022)|
|Quarterly Mean Approval Times||28.82|
|Quarterly Median Approval Times||20.6|
|Quarterly Mean Tentative Approval Times||25.32|
|Quarterly Median Tentative Approval Times||20.31|
Moving into the new month’s statistics, OGD issued approved actions for 52 ANDAs (we hit that number on its head in our post of unofficial approvals here, but as you can also see OGD officially recorded 10 tentative approval actions and we only captured 7 in our unofficial post. So, there were actually 62 approval actions issued in December, not the 59 we unofficially reported. Even though we wait for 4-6 days after the close of the month before reporting approval actions, FDA seems to sneak a few more actions into their official report after that time. Of the 52 full approval actions 10 (19.2%) were first cycle approvals, 6 were first time generics and 7 were imminent actions. Of the tentative approval actions 1 (14.3%) were first cycle approvals and 3 were imminent actions.
FDA’s complete response letters were back down in the 120’s at 124 for the second month in a row. This is much below the historical average. OGD refused-to-receive 5 ANDAs (4 standard and 1 priority). OGD acknowledged 40 new ANDAS in December. OGD also approved 103 prior approval supplements and issued 297 information requests and 210 discipline review letters.
And while there is good news tonight, there is troubling news as well. In the first three months of FY 2023, the number of ANDAs awaiting OGD action has increased each month from 1584 to 1615 to 1678, an increase of about 5%, while the number of ANDAs awaiting application actions has gone down each month from 2177 to 2144, to 2108. While seems to suggest that the OGD ANDA workload is increasing, this view might be blunted by the receipt of 109 ANDA in December, the highest level this FY thus far. Of the 109 ANDA that were received, OGD classified 20 as complex products.
The rest of the metrics look within the usual range and you can review the entire set of the December metrics here.