Powered up my laptop this morning and guess what I found? ANDA, NDA, and BLA approval actions had been updated from their last postings on January 22, 2025 after the pause on communications from the FDA. The best news is that January 2025 ANDA approval actions look great. As of today, the OGD has posed 64 full-approval actions and 20 tentative-approval actions. (Note that two of the tentative approval actions were the second tentative-approval action for the ANDA listed. This could mean either an additional strength became eligible for tentative approval, but more likely that the firm had to submit a substantive amendment that placed the ANDA back into pending status and, upon review, the Agency issued another tentative approval letter. As a result, the counts may be off when the OGD officially publishes its January monthly statistical report).
The good news is that there is a total of 84 approval actions. However, for the rest of the OGD webpages we search daily for news and information, the pause on communication still seems to be on everything but safety information—there is nothing since January 17th on the FDA’s “What’s New” page.
Reminds me of the old Abbott and Costello Niagara Falls routine “Step by step, slowly I turn”! Who knows, maybe tomorrow we will see the falls in the distance (just like Abbott and Costello) along with some more restored information on FDA webpages!
