So, after Monday’s blog post, All’s Quiet On the Eastern Front (here), I woke up this morning to the first signs of at least some normality at the OGD. First, ANDA approval numbers began appearing on the Daily Approvals page and the Small Business and Industry Assistance webpage. On top of that, the first day of the Generic Drugs Forum (GDF) 2025 went off without a hitch.
Based on the restart of the publication of ANDA approvals, we can now report an unofficial March ANDA approval summary. Remember, these are unofficial as changes could occur prior to the FDA scrubbing the numbers but, based on the data posted, it appears that the OGD issued 54 full-approval actions along with 23 tentative-approval actions for a total of – you guessed it – 77 approval actions in the month of March! Postings are up through April 7th so it looks like we’ll have a reasonable estimate of the status of monthly approvals totals and won’t have to wait for 2+ months for the official numbers.
We will report more on how the Agency is progressing with the new organization as well as on what we hear through the grapevine as the weeks and months go forward. But, at least for today, the news is promising!
