Well, in my book, any movement on 505(j)(2)(C) ANDA suitability petitions is welcome news. The pool of pending ANDA suitability petitions is full at FDA and is, by now, becoming very stagnant. There has been little action on 505(j)(2)(C) petitions in the last 10 years. Just last year, out of the blue, we got two petitions approved that were 7 years old. It was a surprise that even shocked us! Least I remind you that there is a statutory provision that requires these petitions be acted on by FDA with 90-days.
To give you an idea of the lack of attention to suitability petitions that are used to make a minor change in the NDA product, according to the FDA website, the suitability tracking list (here) was last updated in 2015. These petitions can be used by firms to request changes in dosage form, strength, route of administration (none ever approved for this change), or a change in active ingredient in a combination product where the proposed changed ingredient is of the same therapeutic class and there is a known equipotent dose relationship between the ingredients (i.e,. codeine phosphate and hydrocodone bitartrate mg/mg ratio of 1 to 6). The FDA is required to approve the petition if the proposed change does not raise question of safety or efficacy and there are no clinical trials necessary to support approval.
I will say that we did detect some movement on a few petitions lately but have not seen any final actions. The revised MaPP 5240.5 Rev.2, can be found here. It was originally issued in August 2013 with its second revision coming in August 2018. Revision 2 is now operative and lays out the internal procedures, in excruciating detail, as to how these petitions are handled and their circuitous route thought CDER they must take before a decision is reached and a final action is taken.
For the most part, firms had given up on the 505(j)(2)(C) petition because the petitions, once submitted, just fell into a black hole and instead firms decided in many instances to submit 505(b)(2) applications for the same changes. This is not how the system was supposed to work but, like a famous politician that shall remain nameless said, “it is what it is!”. Now all FDA has to do is execute the MaPP and get the backlog of petitions (that we estimate to be in the neighborhood of 150-250 [we can’t really say for certain because the list is over 5 years old]) reviewed and take a final action.