On December 19, 2024, the FDA finalized its reexamination of its initial decision (on October 2, 2024) that the tirzepatide shortage had been resolved. This comes after compounders of the drug ran to court to challenge the Agency’s initial decision. The latest notice of the shortage’s resolution came yesterday in a declaratory letter (here), issued by the […]
The Generic Drug Cluster is a consortium of top regulatory agencies from around the world that get together to discuss common issues related to the drug approval process in an effort to better understand how each agency approaches various topics. Hopefully, these discussions will result in developing regulatory strategies that reflect the best and most […]
As of December 15, 2024, just seven business days before Christmas, the OGD has issued 23 full-approval actions and 11 tentative-approval actions. With the holiday quickly approaching and facing what is likely a full FDA vacation schedule, what will the end of the month look like? A total of 34 full and tentative approval actions at […]
The Association for Accessible Medicines (AAM) recently mentioned a report titled “Study: 57 Percent of Covered Generic Drugs Not on Part D Generic Tiers in 2025” (here), conducted by Avalere, that raises serious questions regarding the Centers for Medicare and Medicaid Services (CMS) placement of many generic drugs on higher tiers, which are usually reserved for brand-name […]
According to the first FY 2025 Generic Drugs Program Monthly and Quarterly Activities Report (here), the OGD had a good month for approval actions, issuing 62 full-approval actions and 20 tentative-approval actions for a total of 82. Only one month in FY 2024 had a higher combined total for these two metrics. That’s the good news! The […]
As of postings today on the Recent New and Generic Approvals site (here), the Office of Generic Drugs (OGD) has issued 58 full approval actions and 12 tentative approval actions for a total of 70 actions in November 2024. In our unofficial count for October 2024 reported in our blog post here, we reported that […]
For certain “companies that first registered with the FDA during the COVID-19 public health emergency (PHE) solely for purposes of manufacturing OTC hand sanitizer products during the PHE were not identified as facilities subject to the OMUFA facility fee, for a certain time period. That time period, which extended beyond the end of the PHE, […]
We all know what an expiration date is, or what it is supposed to be, for a drug product. It is a date after which the product could begin to lose its label-stated claim of the drug potency. For some products (like prescription tetracycline), degradation products could form post expiration date that could make taking […]
For those of you who follow the daily approvals page (here), on November 21, 2024, there was a flurry of supplemental labeling approvals listed for drug products that contain non-steroidal anti-inflammatory drugs (NSAIDs), from aspirin to Zipsor (diclofenac potassium). In today’s CDER Drug Safety-related Labeling Changes (SrLC), the new, revised warning that must be included was […]
Having been around the block more than a few times, the position of the FDA regarding pricing is clear. The Agency is not supposed to take pricing considerations into drug approval or enforcement decisions. However, there is controversy swirling around the FDA’s recent decision on the drug shortage for GPL-1 obesity medications and the practice […]
