In the Generic Drug User Fee Amendments Reauthorization Act (GDUFA II), OGD committed to provide a quarterly report with certain metrics regarding their workload and mean and median approval times for full approval actions and tentative approval actions. As you can see from the numbers below, the number of ANDAs awaiting action at OGD is fairly consistent for the first three reporting quarters of FY 2020 as well as the applications awaiting applicant tentative approval. In addition for the first time in a while the number of applications awaiting applicant action (in the hand of industry)has dropped quite a bit.

Mean and median approval times median approval time averages in the 20+ month time frame while the mean is much higher.  This is likely due to older application cohorts moving through the system.  The same is true for mean and median times to tentative approval where the corresponding times are significantly higher.  The impact of the 30-month clock for resultant patent challenges and potential delays in approval for exclusivity may drive the longer time to tentative approval.

First Quarter October – December Second Quarter January – March Third Quarter April – June Fourth quarter July – September

ANDAs awaiting FDA Action

1752 1656


ANDAs awaiting Applicant TA

449 452


ANDAs awaiting Applicant Action 1755 1831


Mean AP Approval Time – Action Cohort

28.15 32.37


Median AP Approval Time – Action Cohort 20.70 25.58


Mean TA Approval Time – Action Cohort 26.55 27.40


Median TA Approval Time – Action Cohort 20.25 24.15


The full report with additional explanation and definitions of the terms used in the table can be found here.  Not sure how the industry feels about these numbers but they do show some improvement from previous years and do not expect them to improve much until the Agency and Industry solve the first cycle approval conundrum.  I would be happy to hear about your thoughts on the latest data and how it impacts your organization.