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 second day of the Generic Drugs Forum provided a significant amount of new and rehashed data, including explanations and suggestions regarding certain application submission issues, including but certainly not limited to DMFs, data integrity and the ongoing nitrosamine saga. Here are a few of the helpful hints presented: When providing amendments to DMF, the […]
Here are some helpful tips and reminders regarding ANDA submissions, patent certification requirements, notice requirements and a couple of Orange Book gems. Please note that not all requirements are listed, and that this just highlights some of the issues discussed. Later listed patents after ANDA submission but before approval must be addressed if the patent […]
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 […]
In a post on the FDA Law Blog (here), Kurt Karst, Director, Hyman Phelps & McNamara, did a masterful job of outlining some of the FDA budget legislative proposals for 2027. I’ve known Kurt for a very long time, and we usually agree on most topics; however, his take on one of the elements appearing […]
A few months before the end of 2025, the FDA requested that Glaxo Smith-Kline (GSK) revise its approved labeling by submitting a supplemental application to its Wellcovorin (leucovorin calcium) to include an indication for cerebral folate deficiency (CFD), a rare disorder. This came after Secretary Kennedy’s thus far unsuccessful hunt for the cause of autism. […]
