Well, here we are, just a tad over halfway through the shortest month of the year. That’s right, there are only twenty-eight days in February, and one of them is a holiday. This February there are only nineteen business days during which OGD approvals can occur. Today, we can report on approvals posted through February […]
January saw the highest number of full ANDA approval actions in FY 2026 thus far at 59 (one more than the 58 from November) along with 19 tentative-approval actions for a total of 78 approval actions for the month. This figure places January as the second highest in total approvals, also behind November, for the first […]
The official Generic Drugs Program Monthly and Quarterly Activities Report for December 2025 has been published and it covers the complete first quarter (October to December) of FY 2026. Let’s take it by the numbers. In December 2025, the OGD approved 46 ANDAs, the lowest monthly total in the first three months of FY 2026. […]
Great National Championship game last night right down to the wire! And today we’re halfway down to the wire on January approvals with actions reported through January 15th on the OGD’s daily approvals page. Thus far, the OGD has issued 25 full-approval actions and 7 tentative-approval actions for a total of 32 approval actions. If the […]
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 […]
