When we reported the unofficial January approval actions in a previous blog post, there was some concern about how OGD would be reporting their approval and tentative approval actions on the daily report versus the Generic Drugs Program Monthly and Quarterly Activities Report (here). If you go back and read the January unofficial approval blog post (here), you can see what my concerns were. But after seeing the official numbers in the Generic Drugs Monthly Report referenced above, not only am I still confused, I also can’t reconcile the differences in the numbers. So rather than spend an eon of time trying to figure it out and then trying to explain the almost unexplainable, I will just report the highlights of the official statistics for January and leave it at that!
OGD issued 56 approval actions in January and of those, four (4) were first time generic approvals and nine (9) (16%) were first cycle approvals with nine (9) of the actions being imminent approval actions (which I believe translates to a goal date being missed, so the final approval action could be taken in a timely manner. This was one of the newer initiatives of GDUFA III and is now being reported). Tentative approval actions totaled 20 of which two (2) (10%) were first time approvals and one (1) was an imminent action.
Complete response letters bounced back to 140 but are still below the 151 monthly average for the previous FY. Five (5) ANDAs received refuse-to-receive letters, same as last month – let’s hope the slight but increasing trend does not continue. OGD acknowledged 83 new ANDAs in January.
OGD reported that it approved 94 prior approval supplements in January. OGD issued 326 information requests (170 for original ANDAs and 156 for supplemental applications). Discipline review letters were the lowest of the first four months of the FY with 179 issued, well below last FY’s average of 204. Applications pending before OGD dropped a bit from last month’s 1678 to 1646 while ANDA awaiting applicant action went up by three (3) this month to 2111.
OGD received only 40 ANDAs in January. The 4-month average thus far in FY 2023 is 70/month. If we project a straight-line trend, OGD will likely receive about 840 ANDAs in FY 2023, 17 lower than last FY. Of the 40 new ANDAs received, five (5) were for complex generics.
All of the other statistics, which can be reviewed in the link at the beginning of this post, remained consistent with previous months so far this FY. Lots of numbers to digest, hope you don’t get acid reflux after reviewing them.