In December, the third month of FY 2026, the number of unofficial approval actions fell significantly from those in the first two months, with the OGD issuing 41 full-approval actions and 13 tentative-approval actions for a total of 54. * December numbers are unofficial but should be close to final. The reasons are not obvious as […]
The official November 2025 OGD statistics are in the books and, as far as approvals are concerned, the OGD had a good month with 58 full approvals and 26 tentative approvals reported. Of the 58 full approvals, 6 were for first-time generics; however, only 6 (10%) were first-cycle approvals. This is one of the lowest […]
November 2025 output picked up as the OGD issued 59 full-approval actions and 25 tentative-approval actions in the month. The total of 84 approval actions is the highest since June 2025 when the OGD issued 89 approval actions. It’s also an improvement over October 2025’s output of 75, the first month of the new fiscal […]
We’ve been waiting for the first Generic Drugs Program Monthly and Quarterly Activities Report to be published for FY 2026, and it arrived sooner than expected! There’s at least one surprise and there are a few other interesting observations that we will discuss regarding new ANDA submissions for October 2025. But first, let’s talk about approvals. […]
Don’t blink – things can change in a minute, or at least in one day. After our blog post yesterday on mid-month approval actions for the OGD, a flurry of activity occurred in the postings from a few days past. The new mid-month approval actions can now be reported as 38 full-approval actions (that’s 12 […]
From a historical perspective, I can’t remember when the turmoil at the FDA was greater, nor can I remember when the morale was lower with perhaps the exception of while the generic drug scandal of the late 80s was occurring. However, despite all the turmoil and the distractions, the Office of Generic Drugs (OGD) has […]
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 […]
