With only the September metrics left to round out the FY 2022 statistical report for the OGD, let’s take a look at the full official numbers for August. We also now have a good idea how FY 2022 will stack up against FY 2021, albeit a lot can happen in a few weeks as we await the final numbers from month 12 of FY 2022.
The OGD issued four refuse-to-receive letters in August for an eleven-month total of forty-two. The FY 2021 total was forty-six so the number of RTRs has a chance to be lower than last FY (if the OGD issues three or fewer in September), which is a good thing. The OGD sent out fifty-six acknowledgement letters in August.
Of the seventy-five approval actions issued in August, the OGD reports that nine (12%) were first-cycle approvals and six were for first-time generics. Of the twenty-two tentative-approval actions that occurred in August, none were approved in the first review cycle.
The OGD had a better month for the issuance of information requests (349) compared to July (291) but the August figure was just slightly above the eleven-month average of 337. Discipline review letters hit the third highest of the year at 231, behind the leader, July, at 314.
Changes-being-effected supplements popped back to just under 800 at 788, and the eleven-month total stands at 7,017, compared to the full FY 2021 total of 9,557. Thus, the number of CBE supplements looks to be in the neighborhood of almost 2,000 less than last year. Controlled correspondences were at 297 for the month and it appears, absent a big surge in CCs being reported in September, that we will likely see about 400 or so fewer CCs than last fiscal year.
To see the complete August statistical report for the OGD, click here.
