In a prepublication of a Federal Register notice (here) that will publish on March 3, 2021, the FDA has announced its intention to refuse to approve the 505(b)(1) NDA originally filed by Sanofi and now held by Lexicon Pharmaceuticals for Sotagliflozin Oral Tablets, 200 mg and 400 mg. The product was intended to be indicated […]
There appears to be some concern about Janet Woodcock, MD being selected for the permanent FDA Commissioner job. Not sure why there is so much hype and concern. Most of the pressure being applied from the non-supporters focus on the opioid crisis; however, some critics are being quick to complain about the approval actions that […]
As we have seen in the news lately, the SARS-CoV-2 virus is spinning out new variants as it replicates in infected individuals. Some of these new variants have been found to be more infectious (and possibly more pathogenic) than the initial virus that first entered the human population. The good news is that the FDA […]
OGD released its official numbers for approval actions, complete response letters and ANDA original receipts for January today, as well as updating metrics for December 2020. From our unofficial numbers reported for January, we hit the numbers of full approval actions on the nose at 62, but OGD snuck in an additional tentative approval action […]
Let me start off by saying you all know that I am a bit bitter about the lack of activity on the 505(j)(2)(C) ANDA suitability petitions. So, in an attempt to soothe my nerves and calm myself down, I looked back to January 1, 2020 to see how many ANDA suitability petitions have been filed […]
In the first 10 business days of February 2021, the Office of Generic Drugs has issued 30 full approval actions and 3 tentative approval actions for total approval actions thus far at 33. There are 9 business days left in this month and, of course, February is only 28 days in total. Even if the […]
The generic community sprung into action with amicus briefs filed by the Association of Accessible Medicines and letters written by various other organizations to challenge the attack on the skinny label. Teva was able to convince the Court of Appeals for the Federal Circuit to rehear its skinny label case. Clearly, Congressional intent and regulatory […]
Today, The Hill hosted a webinar called “Complex Generics & the Prescription Drug Landscape.” Many thanks to The Hill for their efforts. The takeaway messages from the program participants are important, especially as the current Generic Drug User Fee Amendments III (GDUFA III) negotiations are revving up for the Office of Generic Drugs’ review and […]
When FDA approved the Pfizer drug product tofacitinib (Xeljanz, Xeljanz XR), which treats arthritis and ulcerative colitis by decreasing the activity of the immune system, they required that Pfizer conduct post-approval safety trials to evaluate the risk of serious heart-related events, cancer and infections. Tofacitinib is offered in two strengths which were both studied in […]
Interoperability in healthcare has been discussed for decades and is one the greatest challenges to be overcome in medicine. Not only because technical barriers exist, but because physicians practice medicine and research continue to push the boundaries, creating new terms to be defined and understood. In addition, the rate of this is accelerating (witness the […]
