November 2019 Approvals and Receipts Official Numbers

Based on our post previewing the November totals, there were some late added approvals that did not initially show up on the Agency approval databases.  We reported 49 full approval actions and 8 tentative approval actions on December 3rd.  With the release of the official November numbers (here), OGD issued 59 full approval actions and 10 tentative approval actions,for a total of 69 approval actions for the month or 4 more than last month (57 full and 8 tentative approval actions).

Complete Response Letters (CRLs) dropped from 197 in October to 156 in November 2019.  The low for FY 2019 was 144 CRLs in December 2018 and September 2019 with a high of 235 in May 2019.  Average number for FY 2019 was 193, for FY 2018 it was 221, and for 2017, it was 133.  Not sure why this number fluctuates, but this metric appears to pop up and down.  With the OGD workload fairly constant, one would think that, if approvals are low, CRLs would be higher, but according to OGD, that assumption is not reliable.

OGD received 57 ANDAs in November, two less than in the first month of FY 2020.  It is way too early to give any reliable predictions for how FY 2020 will turn out, but we are certain FY 2020 is off to much slower start than in FY 2019 (see yearly FY 2019 figures here).