The FDA is warning about a serious and potentially fatal adverse event that has been reported with use of the antiseizure medications levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan). The ADE, called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), is extremely rare and the “FDA’s cumulative review found 42 serious […]
Not sure what is taking the FDA so long to fix the system “glitch” in reporting ANDA approval actions, but this has been going on for quite a while. Here we are, the day before Thanksgiving, and there are only 14 full ANDA approval actions and 9 tentative approval actions listed in the available FDA […]
Just like the FDA says on its warnings and notifications page (here): “It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers. FDA cannot test all products on the market that contain […]
I am sure that any of you that have listened to radio or watched TV have heard a prescription drug ad and have struggled with keeping up with the fast talking and not so slow walking people, scene, or scrolling of text on direct-to-consumer ads. FDA has been working to develop standards over the course […]
This has been a tough year for pharmaceutical companies, with price concerns on the tip of everyone’s tongue, the race to the bottom on generic drug pricing and its impact on drug shortages, FDA now back almost fully in the facility inspection mode, Warning Letters flying out of the Agency at a breakneck pace, and […]
On September 30, 2023, the Animal Drug and Animal Generic Drug User Fee Amendments of 2023 were signed into law as part of H.R. 5860. The amendments reauthorize the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) programs administered by the U.S. Food and Drug Administration until 2028. But not […]
August was an even better month than we predicted in our post on September 8th (here). There were actually 98 (instead of 96) full approval actions and 12 tentative approval actions for a total of 110 approval actions. The two (2) approvals missed likely were at the end of the month when we first discovered […]
In a rousing session at the AAM’s GRx-Biosims conference, Kurt Karst, J.D., Director, Hyman, Phelps & McNamara, Brian McCormick, J.D., M.H.S., Vice President and Chief Regulatory Counsel, Teva Pharmaceuticals, and Chad Landmon, J.D., Partner, Axinn, Veltrop & Harkrider LLP gave a presentation entitled 180-Day Exclusivity: What Is Past Is Prologue or, as they like to […]
The new Form FDA-356h was released in July 2023. The FDA’s expectation is that the newly revised form (which has an expiration date of March 31, 2026) should be utilized when submitting new drug applications, abbreviated new drug applications, and biologics license applications for human use. The new form can be downloaded from a link that […]
There is a new proposed piece of legislation that appears to give approved holders of ANDAs the right to unilaterally revise their labeling to provide new safety information that is not found in the labeling of the reference listed drugs (RLDs). Over the years, many proposals have been put forward to change the way that […]
