As I was sitting at the AAM’s GRx-Biosims meeting this week listening to the presentation from Dr. Iilun Murphy, Director of the Office of Generic Drugs, I clicked on a link on my computer for the Generic Drugs Program Monthly and Quarterly Activities Report and noticed that the report had been just updated with the […]
Dr. Iilun Murphy, Director of the Office of Generic Drugs presented on the State of OGD. Some interesting numbers presented include the fact that OGD received only 600 new ANDAs in FY 2025. She acknowledged that the pace of ANDA submissions was way down (from 740 in FY 2024). OGD on the other hand approved […]
The first month of the new fiscal year (FY 2026) appears to have gotten off to a slightly slower start than anticipated with the OGD reporting 23 full approval actions and 12 tentative approval actions. While there were 23 full approval actions, one of these represented a second strength of a previously approved product so it […]
Today, the FDA posted its August 2025 monthly statistical report, and with FY 2025 ending on September 30, 2025, we’re only one update away from the official numbers for the full fiscal year. The August update indicates that the OGD did, as previously reported, fully approve 47 new ANDAs and (at OGD official count for the monthly […]
It has been a slow go for the first half of September, which is the last month of FY 2025. So far this month, there have been just 17 full-approval actions and 4 tentative-approval actions posted on the FDA daily approval page (here). This is the lowest number of approval actions midway through any month that […]
Here are some of the highlights of the recently issued Generic Drugs Program Monthly and Quarterly Activities Report for July 2025. For more details or to review the full report, please click here. Our analysis appears below. As we noted in a previous post (here), the OGD fully approved 52 ANDAs in July 2025, which […]
August was the slowest month for approval actions in FY 2025 and, now that we’re in September, let’s hope that this will not become a trend. The OGD issued 47 full-approval actions, the lowest of this fiscal year, with February the second lowest at 53. As far as tentative-approval actions, the OGD issued 14, also the […]
As of August 15th, the OGD has issued 28 full approval actions and 7 tentative approval (TA) actions. When the Generic Drugs Program Monthly and Quarterly Activities Report is issued, the total number of TA actions will be decreased by 2 based on the fact that two are for second TA action letters issued thus […]
The OGD published its official June 2025 Generic Drugs Program Monthly and Quarterly Activities Report (here) and it comes with some good news on approval times for the quarter but some not-so-good news in terms of new ANDA submissions. Please review the entire report at the link above to see all of the metrics reported […]
July, while in the books at least unofficially, got off to a slow start but it picked up towards the middle of the month. I guess the fireworks on July 4th distracted everyone as the burst of colors adorned the skies! Anyway, during July, the OGD issued 52 full-approval actions and 13 tentative-approval actions for […]
