As we approach the last week in March, we now have one-third of FY 2025 behind us. January’s ANDA approval numbers continue to look good, as we discussed in our February 6, 2025 post on the unofficial January approval actions (here). Another month with 90 total approval actions is good news for industry. The monthly total is broken down into 63 full-approval actions and a whopping 27 tentative-approval actions.

Of the 63 approval actions, nine were for first-time generic approvals and eleven (17.5%) were first-cycle approvals. Of the 27 tentative approvals, five (18.5%) were first-cycle approvals. I believe that the OGD needs to take a closer look to find out what factors are preventing ANDAs from being approved in the first cycle. If the OGD can find out what those factors are and communicate them back to industry in an actionable manner, then that will certainly improve the OGD’s efficiency.

With 250 ANDA approvals in the first four months of the year, we could be looking at 750 approvals for the full fiscal year. That would put the yearly approval total at 56 more than last fiscal year.

The OGD issued only one refuse-to-receive letter in January. The OGD also issued 123 complete response letters, the most of any month so far this fiscal year, and it approved 138 prior approval supplements. Information requests sent out in January totaled 356, with 195 for ANDAs and 161 for submitted supplements. There were also 160 discipline review letters issued to firms.

As far as the monthly reported OGD workload, the number of ANDAs awaiting FDA action stands at 1,384, the lowest since December 2023, when that total was 1,646. Remember that this metric was first added to the monthly statistical report in October 2023. The number of ANDAs awaiting applicant action was the highest this fiscal year at 1,956 with the OGD is expecting responses to 544 tentative approval letters and 1,412 complete response letters.

On the receipt side of the ledger, the OGD received only 39 ANDAs in January. The four-month total of new ANDA receipts equaled a mere 151, which would translate to only 453 new ANDAs expected to be submitted in the full FY 2025 if the average monthly submission rate stays the same. This would be the lowest number of ANDAs received since well before GDUFA and would present an interesting problem when it comes to addressing the new ANDA GDUFA fee for FY 2026. The lower the number of ANDAs, the higher the ANDA GDUFA fee will be, and after last year’s steep increase, I’m sure we will hear some big squawking from industry if that occurs. It is unclear how this will play out, given the reduction in force at the FDA and layoffs happening and anticipated in the generic drug program, as this could certainly reduce staffing costs unless the same number of full-time equivalents (FTEs) are maintained under the user fee program.

Amendments received by the OGD totaled 166, which are broken down as 53 major, 60 minor, and 53 unsolicited amendments. The OGD received 895 supplements, 735 being for changes being affected (CBE) and 160 for prior approval supplements (PAS). Controlled correspondences received jumped up to 348, the highest this fiscal year.

The full report, which contains many other interesting statistical metrics in addition to those mentioned in this post, can be reviewed here. What is your take on the lower number of ANDAs being submitted? We would love to hear your views. Please send them to r.pollock@lachmanconsultants.com.