The OGD unofficially issued 53 full approval actions and 16 tentative approval actions for a total of 69 approval actions.  For a month with only twenty-eight days and one federal holiday, the OGD’s approval-action total is not too bad.  Coupled with the great uncertainty regarding terminations and reduction in force of CDER employees, I think that the OGD did pretty well, even though it produced the fewest total number of approval actions in FY 2025 thus far.

Usually, we do a projection of potential full-year approvals and new ANDA submissions each quarter.  However, we did not do that when presenting the official statistics for the first quarter so here it goes.  For the first three months of FY 2025, the OGD approved 187 new ANDAs, and, if that trend continues, we can expect a full FY 2025 total of 748 ANDA approvals, which would actually beat last fiscal year’s total of 694 (which was the lowest since 679 ANDAs were approved in FY 2021).  That would be good news for the OGD.  On the other hand, with the number of new ANDA receipts totaling only 112 in the first quarter, if that trend continues, we can expect to see only 478 new ANDAs.  While that seems abysmal, we have to remember that firms rushed to submit 140 new ANDAs in September 2024, just prior to the large increase in the ANDA User Fees that went into effect on October 1, 2024.  So, hopefully we will see the numbers looking better as FY 2025 progresses.

New ANDAs are the lifeblood of the OGD, just as ANDA approvals are the lifeblood of the generic industry.  And considering the current political climate, if there is a hint of a reduced workload, there is a possibility of additional layoffs in the generics program.  We certainly hope that the current administration sees the continued value of generic drugs in lowering prescription drug prices and won’t throw the baby out with the bathwater if there is a single bad year for ANDA receipts, but you never know.

We will be back to you with the official February 2025 statistics, which will likely be posted about two months from now.  We are also awaiting the official January 2025 statistical results, which will include approvals and new ANDA receipts as well as those metrics typically found in the monthly statistical reports.  We will keep you posted!