It appears that 128 is the magic number for the OGD as last month they also had 128 approval actions. November numbers saw a different split between full approvals and tentative approvals (99 and 29, respectively). The 128 total approval actions obviously ties last month record number of approval actions for a single month.
Of interest, the number of Complete Response Letters are back up close to the mid-200s at 230. The number of new original ANDAs submitted to OGD in November (54) is the lowest number of submission in the last twelve months.
As noted above, the OGD also updated its October statistics. Refuse-to-Receive actions numbered seven, with six being standard review applications and one being a priority GDUFA II application. The OGD reports acknowledging fifty-four ANDAs, which is the second lowest number of acknowledgement letters since the beginning of GDUFA II
Looking back to October, OGD fully approved 110 ANDAs, with twenty-four (21.8%) being reported as first‑cycle approvals and eighteen as tentatively approved ANDAs, with five (27.8%) of these being reported as first‑cycle approvals. The overall first‑cycle approval percent for all approval actions was thus 22.6%, a stunning increase from past numbers reported for first‑cycle approvals.
October was another big month for CBE supplements with 596 being submitted; controlled correspondences at 240 submitted was the fifth highest month since GFUDA II.
The FY 2019 numbers reported here can be accessed here.
