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 this blog, I often rail about how unapproved drugs and illegal dietary supplements find their way into the U.S. market through the internet or mail outlets. I’ve wondered why the FDA is not doing more to stop the game of whack-a-mole where, as soon as the FDA makes an enforcement action against one supplier, […]
We posted a blog earlier today (here) regarding the FDA’s announcement that it plans to review a number of drug substances at a two-day meeting, in July, of the Pharmacy Compounding Advisory Committee. Later in the day, the FDA released a document outlining additional plans to reclassify other drug substances, including several peptide drug substances, […]
The FDA has announced a two-day meeting of the Pharmacy Compounding Advisory Committee for the purpose of reviewing certain bulk drug substances nominated for inclusion in the Section 503A bulk drug substances list. The meeting is scheduled for July 23-24, 2026, and it will be held at the FDA’s White Oak Campus. The full notice from 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. […]
Today, the FDA issued yet another health warning regarding an unapproved sexual enhancement product marketed as an over-the-counter drug and, boy, is this one a doozy. It contains sildenafil and tadalafil, the active ingredients in approved Viagra and Cialis, while also containing, flibanserin, which “is the active ingredient in Addyi, an FDA-approved prescription drug used […]
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 […]
