The metrics for June appear to be in line with those of other months this FY. There were no big surprises. Here are some of the highlights.
The OGD issued only three Refuse-to-Receive (RTR) letters in June, with one for a standard ANDA submission and two for priority submissions. It still seems that priority submissions are more likely to receive RTR letters, possibly because of the rush to get the applications into the Agency. The OGD acknowledged fifty‑nine new ANDAs in June.
Of the previously reported forty-five approvals issued in June by the OGD, only four (or 8.9%) were first‑cycle approvals and, of the seventeen tentative approvals issued, there were no first‑cycle approvals reported. First‑cycle approvals have been topping double digits for a while now. Let’s hope this drop in first‑cycle approvals doesn’t signify a looming problem.
Complete Response Letters (CRLs) rebounded to 169, a bit higher than the monthly average this year of 154.2 and in line with last year’s monthly average of 167, but still falls well below the monthly average of 192.5 seen in FY 2019. Information requests issued by the OGD totaled 352, in line with FY 2021 expectations, while discipline review letters hit a high for the FY at 253, beating the previous high monthly total for FY 2021 of 204 in March.
Changes Being Effected (CBE) supplements submitted were reported at 795, lower than the monthly average of 819, while prior-approval supplements hit a FY high thus far of 128. And lastly, Controlled Correspondences (CCs) jumped back over the 300‑mark at 336 for the first time in three months.
The full set of monthly metrics for June can be reviewed on the Generic Drugs Program Activities Report – Monthly Performance here.