Let me start off by saying you all know that I am a bit bitter about the lack of activity on the 505(j)(2)(C) ANDA suitability petitions. So, in an attempt to soothe my nerves and calm myself down, I looked back to January 1, 2020 to see how many ANDA suitability petitions have been filed and how many have been acted upon in that time period.  Just to remind you, ANDA suitability petitions by statute and regulations are required to be responded to in 90 days.

Here is what I found!  Since January 1, 2020 through today, there have been 18 ANDA suitability petitions submitted to the Agency.  There have been 7 final actions (all approvals by the way) issued by FDA over that same time period.  Given the inaction on petitions, one might think, well, that isn’t too bad, maybe FDA is actually paying more attention to the submissions.  However, none of the petitions submitted since January 1, 2020 have been acted upon.

Here is a listing of the FDA actions and the dates the petitions were originally submitted to FDA

Petition Number Date Received by FDA Date of Action by FDA
FDA 2012-P-1251 12/19/12 02/09/21
FDA 2015-P-0477 12/11/15 02/04/21
FDA 2015-p-4959 12/21/15 11/30/20
FDA 2016-P-1088 03/23/16 11/18/20
FDA 2018-P-3770 09/05/18 10/16/20
FDA 2015-P-0596 02/25/15 07/08/20
FDA 2013-P-0945 08/05/13 04/17/20


The petitions that were responded to by the Agency over the last year were originally submitted between 2012 and 2018, with most submitted 5 years or more ago and the oldest about 9 years ago.

It does look like the ANDA suitability petition submissions are rising again and that it is believed to be because of hope that new legislation, FDA comments, and GDUFA III negotiations all point to a renewed interest in moving the large backlog of suitability petitions along.  It is not easy tracking these things down since FDA’s listings of petitions has not been updated since 2015.  This data was extracted from the regulations.gov website in a painstaking process (that did not calm me down at all).  It should be noted that all of the FDA actions issued over the last year were for new strengths of existing products. These petitions are the easiest to answer. There were no denials issued, as those responses require considerable efforts by various FDA organizational components (usually including the Office of Chief Counsel).  However, with a resurgence of suitability petition submissions, perhaps the Agency’s actions do signal a bit of an uptick on attention to these petitions.