The approval metrics look very similar to previous months during this fiscal year but there is good news on the number of new original ANDAs received. Let’s take a look! The OGD approved 56 ANDAs in March, 7 of which were first-time generics and 17 (30%) were approved in the first cycle. This 30% represents […]
The number of approval actions that were posted for the first half of April 2026 might be a record. The FDA issued 59 full-approval actions (helped a great deal by full approvals of 24 ANDAs and 5 tentative approvals on April 6th for Dapagliflozin single entity and combination products on the day of the expiration of the […]
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 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 […]
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 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 […]
As is the case with most negotiation sessions, no agreements were made at this time on the issues discussed. This is a back-and-forth process and the norm as negotiations proceed; the ultimate FDA decision-makers must weigh in on the issues prior to agreement. The full minutes of the meeting can be found here, and some […]
Today, the Office of Generic Drugs announced the issuance of 98 Product-Specific Guidances (PSGs). The guidances can be accessed here. In an email announcing the availability of the newly issued guidances, the FDA said: “Today’s batch of 98 PSGs (31 New and 67 Revised) contains: 68 PSGs for products with no approved ANDAs (including 31 complex products) 46 PSGs […]
The Association of Accessible Medicines (AAM) continued Day 1 with a discussion of what’s happening on Capitol Hill and how we can be working to position industry priorities with policymakers to make the most positive impact on patient access. The session was conducted as a fireside chat hosted by Mark Ratner, Senior Vice President, Government Affairs, […]
We now have official statistics for one-third of FY 2026. While the number of full approvals hit a high (by one) for FY 2026, the number of new ANDA receipts in January were disappointing. Let’s take a look at the most significant statistical metrics for the current report. As far as FDA actions, the OGD fully approved […]
