It’s another month of full stats in the books, but not much to cheer about. Let’s have a look at some of the highlights (or lowlights, if you will) of the month’s statistics.
OGD Refused-to-Receive (RTR) 4 ANDAs in July and all four were for standard ANDAs. The average RTRs per month through the first 10-month period of FY 2021 was 4.2. OGD acknowledged 53 new ANDAs in July.
Withdrawals hit a high for the year at 49 in July, with 35 approved ANDAs withdrawn and 14 unapproved ANDAs withdrawn. Coming close to the end of the FY, this could be because firms may be eyeing the number of approved ANDAs they own in preparation for having to calculate whether they fall into the small, medium, or large manufacturer status for the purposes of paying the yearly program fee.
Of the 46 ANDAs approved in July, 10 (or 21.7%) were first cycle approvals. This smashes the % of first cycle approvals from June (8.9%). Of the 9 tentative approvals in July, 2 (or 22%) were reported as first cycle approvals. This is a marked improvement over June’s 0%.
The number of Information Requests (343) was in line with previous months but a bit below the 10-month average of 363. Discipline Review Letters were at 181 compared with the 10-month average of 178.
Changes being Effected (CBE) supplements dropped below 700 (680) for only the third time this FY, where the 10-month average thus far is 804.8. Prior Approval Supplements (PAS) numbered 104, which is just about average.
Controlled Correspondences hit the second highest month at 374, eclipsed only by March’s 402 thus far. Firms appear to still have lots of questions and continue to be risk adverse in taking a chance on something new or different without OGD’s blessing.
The complete metrics reported for July can be found here. See you next month – only two months to go in FY 2021 before we start the last month of GDUFA II.