OGD updated its monthly Activities Report Of the Generic Drug Program FY 2018 for certain statistics that had not yet been posted (here). While we wait for the June 2018 official approval and receipt figures, let’s have a look at some of the interesting May statistics.
OGD reported 8 refuse-to receive (RTR) actions, with an even split between priority and standard review applications. OGD acknowledged 136 ANDAs, the second highest so far this FY, beating only November (161). Of the 67 approvals in May, only 7 were first time approvals, which, by percentage, appears to be the lowest so far this current FY, and, of the 19 tentative approvals, issued in May, only 2 were first cycle tentative approvals.
Information requests (449) were the highest of the FY, with discipline review letter at 216, sliding into the second spot behind the number issued in March of this FY. OGD received more ANDA amendments in May, 232 (107 major and 124 minor and 1 unsolicited amendment) than in any other month this FY. While we are not sure what this really means, with the numbers of first cycle approvals appearing to regress, this could cause the number of ANDA cycles to increase, leading to more amendments being submitted by applicants.
Controlled correspondence also tied the previous record (252), which was registered in November 2017. Changes being Effected (CBE) supplements continue to stay high (574), but, again we don’t know if that is because changes occur over the lifecycle of the applications or because changes must be made after approval but before marketing because of a change that must be made to assure quality of the product or the validation of the process is completed. It would be nice to have more insight and transparency relative to supplemental submissions. The same thing can be said for Prior Approval Supplements (PAS) with May being the third highest month for PAS supplements this FY.
You can try to say a lot about or guess about these numbers, but the problem is that you need years of data and more information on the nature of the applications and types of supplemental changes to make any really concrete definitive assessments.
