On Tuesday, April 7th, the FDA announced that the Office of Generic Drugs had approved multiple first generics for Dapagloflozin Tablets. A quick review of the listings for the product in the Orange Book shows that there were a total of fifteen ANDAs approved on Monday, April 6th, which was the first business day that the FDA […]
The FDA has posted a total of 82 approval actions in March to date on the FDA All Approvals page. Of course, these numbers could change over the next few days as the posting of some applications is delayed. The OGD’s approval pace has been consistent over the past eighteen months. During March, the OGD […]
The FDA and industry representatives reported on two more negotiation sessions held on March 4, 2026 and March 6, 2026, the minutes of which are reported in full here and here, respectively. There was some progress—agreements were made on certain topics, and discussions were foreclosed on others—but it looks like we are getting closer to an agreement […]
Every 3 months, FDA updates its New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System listings (here) to include newly identified potential serious risks that FDA is investigating. The FDA wants to emphasize that “[T]he appearance of a drug or biological product on a quarterly report does […]
On March 20, 2026, the FDA issued a Warning (here) notifying healthcare providers and patients that Carbidopa/Levodopa drug products can cause vitamin B6 deficiency and vitamin B6 deficiency-associated seizures. The warning instructs healthcare providers to monitor B6 levels in their patients taking the combination therapy, and recommends taking a baseline B6 level at the beginning of treatment. B6 […]
Last night, the FDA published the Generic Drugs Program Monthly and Quarterly Activities Report for February 2026 (here). As has been the case lately, there is both good and bad news. Let’s look at the highlights of the report. First, let’s look at the approval metrics. The OGD fully approved 64 ANDAs; of that number, […]
The ongoing GDUFA IV negotiations have shed some light on interesting issues that will apply to the new GDUFA reauthorization period for FYs 2028 to 2032 presently being considered by both industry and the FDA. The full minutes of the February 19, 2026 FDA-industry negotiation meeting can be found here, but I have a brief summary of the […]
Through March 16, the Office of Generic Drugs has issued 30 full approval actions and 7 tentative approval actions. This appears to be about the average number of mid-month approval actions totals we have seen for this current fiscal year. With fewer ANDAs being submitted, it is not clear to me why the approval actions […]
While endotoxin and pyrogen testing might not be the sexiest of topics, they are extremely important topics for creating a safe sterile product. I believe that FDA has made your job easier by their recent publication of the guidance titled Pyrogen and Endotoxins Testing ‒ Questions and Answers (Edition 2) yesterday (here). It contains a […]
The FDA has finalized the Guidance for Industry titled Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs (here). The final guidance is essentially the same as the draft of the same name issued on October 22, 2022 with the exception of minor editorial changes to increase clarity. The use of classic […]
