A sneak peek at the Office of Generic Drugs’ May 2024 approval actions should put a smile on the industry’s face as the OGD hit the highest number of total approval actions so far this FY in May. The OGD issued a total of 84 approval actions last month, consisting of 72 full-approval actions and […]
This morning, the FDA published a reminder (here) that over-the-counter (OTC) monograph user fees (OMUFA) for facilities must be paid today, noting that it “is in reference to the March 29, 2024, Food and Drug Administration Federal Register notice (FRN) titled ‘Over-the-Counter Monograph Drug User Fee Program-Facility Fee Rates for Fiscal Year 2024.’ The fiscal year […]
Well, the numbers look good (as we predicted); however, we missed by a few in our crystal ball calculations. It is possible that at least 2-3 approvals for alternate strengths of previously approved products showed up in the charts, so we were a bit high on the projected full approval numbers (see here) and that […]
A May 28, 2024 review article by Skylar Jeremias titled, “New Evidence Confirms Safe Biosimilar-to-Biosimilar Switching” (here), supports the fact that switching between biologics and biosimilars or from one biosimilar to another does not present a problem. The article states “[S]ince the July 2022 publication of the first systematic review of biosimilar-to-biosimilar switching, the European […]
We have written a lot about fraudulent drugs over the years. Some examples of these include counterfeit drugs, dietary ingredients that are unsafe, dietary drugs that contain undeclared prescription drugs in them, and the list goes on and on. In his presentation titled “Fraudulent Drugs: You’re Taking What?” (here), Brad Pace, Associate Director, Office of […]
The Association of Accessible Medicines (AAM) and the BioSimilars Council (a Division of AAM) released a statement of support (here) for a legislative fix to provide a safe harbor for generic / biosimilar label carve-outs. The issue is the potential threat of litigation for inducement to infringe, a problem that could bankrupt a generic or […]
The current FDA Drug Shortage List (here) identifies 110 drugs in shortage. Please note that the list contains 128 entries, but 18 of the drugs on the list are reported with their shortage status as resolved. In contrast, the American Society of Health-System Pharmacists (ASHP) lists 254 products on its drug shortage list (here). Apparently, […]
April’s unofficial totals for approvals actions were discussed in a previous blog post here, and we mentioned that April showers might bring May flowers. Well, the bloom of approvals so far in May might rival the bloom of flowers that we’re seeing in the California deserts this year! The approval actions posted through May 16th […]
This morning, I was reading an article written by Sally Turner in Pharmaceutical Technology (here), suggesting that the FDA take a greater role in the review and validation of the patents that brand-name companies list in the Orange Book (OB). She addresses the Hatch-Waxman Act’s patent listing provisions and discusses other views held on the […]
Well, it must be true that April showers bring May flowers. A shower of approvals in April is something we haven’t seen in a while. The OGD unofficially issued sixty-eight full-approval actions and eleven tentative-approval actions for a total of seventy-nine for the month. We still must wait for the official numbers to be posted, […]
