The OGD released its May 2026 Generic Drugs Program Monthly and Quarterly Activities Report (here) late Tuesday evening. In our blog covering unofficial May mid-month approval actions (here), we surmised that the final ANDA approval numbers would be significantly lower than the May numbers when the official metrics came out and we were right… they […]
In this morning’s Federal Register pre-notification page (here), the FDA announced the addition of 23 new Product-Specific Guidances (PSGs) and 48 revised PSG documents. The FDA began publishing PSGs on June 11, 2010 when it announced its first group of PSGs to assist firms in understanding the FDA’s current thinking on the bioequivalence requirements for specific […]
We previously noted that April would likely be a good month for OGD approvals, and it was! The OGD approved 85 ANDAs, of which 41were first-time generics; however, only 10 (11.7%) were first-cycle approvals. This low percentage of first-cycle approvals is likely because of the large number of single-entity and combination dapagliflozin products that were approved […]
I had the good fortune to attend the FDLI Annual Meeting held on May 6th and 7th. The FDLI Annual Meeting is always a good conference where attendees are able to hear many great updates from the FDA and insights on issues related to our industry. This year was no exception, and the FDA had a […]
While April showers may bring May flowers, the number of unofficial April ANDA approvals sure is a welcome event. April saw full approval of 87 ANDAs, the highest number since August 2023 when the FDA approved 98. April’s total was bolstered by the 24 full approvals of dapagliflozin single entity and combination products on April 6th. […]
The Generic Drugs Forum for 2026 got off to a great start this morning. The two-day session is covering the “soup to nuts” of interest to generic drug sponsors. Here are just a few tidbits from this morning’s session: The Refuse-to-Receive (RTR) rate for original ANDA submissions dropped from a high of 10.9% in […]
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 […]
