October 2019 Approval Actions and Receipts Reported by OGD

OGD reported the official approval actions, receipts, and Complete Response Letters for the first month of FY 2020.  There were 57 full approval actions and 8 tentative approval actions for a total of 65 approval actions for the month of October (we reported 52 and 9 actions respectively here), so it appears that there were some adjustments made to arrive at the final official numbers (along with some delay in reporting full approval actions).

OGD issued 197 Complete Response Letters in October 2019 (month one of FY 2020) which is right at the monthly average for this metric for FY 2019. The Agency reported that they received 57 new ANDAs in October 2019, compared to 85 received the previous October and well below the FY 2019 monthly average of 76 ANDAs received.

The new Generic Drugs Program Activities Report – Monthly Performance Fiscal Year 2020 that outlines the newly reported numbers can be found here which we just found this afternoon.  We are not certain when It was actually posted, as the “current as of” date listed was October 24, 2019 – which would not actually be possible since it included all of the October numbers.  In addition, the Agency usually provides notice that the monthly report has been updated on What’s New at FDA and that has not yet appeared.  But no need to worry- we found it for you!