Today is January 8th and the OGD just updated the November 2019 metrics (here) with the following information of interest: the OGD refused-to-receive three ANDAs (all of which were standard applications) and acknowledged fifty-five original ANDAs.
There were twenty ANDAs withdrawn in November (two were approved ANDAs that were likely no longer marketed) and eighteen were unapproved applications. So far, for the two months reported, there were a total of sixty-one ANDAs withdrawn and fifty-eight of them were for unapproved applications. This is significant as this means that the OGD workload (or the backlog as we used to call it) is decreasing as firms are likely no longer pursuing some older applications, either due to changing markets, mergers and acquisitions, or the inability to generate the data to satisfy approval requirements.
Of the fifty-nine full-approval actions issued in November, ten were first-cycle approvals, which represents about a 17% first-cycle approval rate for the month. Of the ten tentative approval actions, three were first‑cycle approvals (a 30% rate of first-cycle approval).
Complete response letters fell to 156 and information requests were at 253, both lows for the two months of FY 2020, and discipline review letters dropped to 179 from 188. So, November was a slower month for actions in OPQ review activity.
The number of amendments received by the Agency also dropped from 254 to a normal 188 (compared to FY 2019 figures). Supplements and controls were down slightly from 721 to 669 and from 292 to 246, respectively.
No figures are out yet for official approval numbers or receipts for December 2019. We will report those when they become available.
