Today OGD provided partial information for the typical first reported March Metrics and updated its February 2020 metrics. Let’s start with the new March data.
OGD reports 60 full approval actions and 17 tentative approval actions for a total of 77 approval actions for original applications in March, which is the highest number of total approval actions in any one month thus far this FY. The 60 full approval actions fall in second place this FY with only December (63) exceeding that number. The Agency reports that 8 of the 60 full approvals represented first time generic approvals.
In March 2020, OGD issued 195 complete response letters, which is not out of line with what we have seen in other months this FY. The number of ANDAs surged to 98 in March (which is likely influenced by end of the FY in India) and represents the second largest month in submission of original new ANDAs (149 submitted in December likely due to the end of year crunch).
Now we can back up to the update to the February metrics. Issued only three refuse-to-file (RTR) actions (one for a standard review and two for priority review applications). In a high for the year-to-date, OGD acknowledged 114 ANDAs.
Of the 51 full approval actions issued in February, 4 (or 7.8%) were first cycle approvals. Of the 10 tentative approval actions, 2 (20%) were first-cycle approvals. Also, information requests hit a high for the FY at 355 and discipline review letters totaled 182 for the month.
Amendments received were in line with previous months at 211 and were split about 50/50 between major and minor amendment classifications. CBE supplement submissions were the second lowest thus far this FY at 693 and PAS supplements dipped to only 64 (average 85.6 for the 5-month reporting period. Controlled correspondences continue pouring into OGD with over 300 (303) which will keep OGD busy for certain.
To see the entire Generic Drugs Program Activities Report – Monthly Performance from which this data is extracted please click here.