Based on our post previewing the November totals, there were some late added approvals that did not initially show up on the Agency approval databases. We reported 49 full approval actions and 8 tentative approval actions on December 3rd. With the release of the official November numbers (here), OGD issued 59 full approval actions and […]
In a blog post, Kurt Karst (Hyman, Phelps, and McNamara) addressed at least one very significant issue the proposed Blocking Act of 2019 could have (here). Many believe that the change from the current legislative language may erode the value of 180-day exclusivity and, in the long run, could lead to higher drug prices. The […]
N-Nitrosodimethylamine (NDMA), which was previously found in angiotensin II receptor blockers (the ‘sartans”), which are blood pressure medications, and more recently, in ranitidine (a heartburn medication) has caused nationwide recalls of the products. Now there is a hint that metformin, a widely used drug for diabetes, may be implicated as well, as Singapore’s Health Sciences […]
Reading Derrick Gingery’s article “ANDA Approval Records Will End As U.S. FDA Mops Up Backlog” (here) in today’s Pink Sheet about Dr. Woodcock’s contention that the clearance or “mop up” of the backlog will impact the number of generic drug approvals, I was somewhat stopped in my tracks. Granted, the backlog of old applications did […]
As of the postings both on the FDA daily approvals list (here) and the FDA All Approvals List (here), the morning of December 3, 2019 OGD lists 49 full approval actions and 8 tentative approval actions for a total of 57 approval actions for month two of FY 2020. October has a final official approval […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
In the prepublication page of the Federal Register Notice (here) published today, OGD announced 28 new bioequivalence recommendations and revised 53 previously issued recommendations. While the new and revised guidance documents appear on the listing of Product-Specific Guidances for Generic Drug Development (here), the links to the new and revised documents were not yet active […]
OGD reported the official approval actions, receipts, and Complete Response Letters for the first month of FY 2020. There were 57 full approval actions and 8 tentative approval actions for a total of 65 approval actions for the month of October (we reported 52 and 9 actions respectively here), so it appears that there were […]
With the FDA reporting posted through November 18th, the OGD has issued full-approval actions for just twenty-four ANDAs and has issued tentative approval actions for two ANDAs. Thanksgiving week is a notoriously slow week for approval actions due to the holiday and staff absences, so November looks like it will be a somewhat lean month […]
There have been eighty-six first-time generic approvals for the calendar year 2019 thus far, at least through November 8, 2019, according to the updated list by the FDA (here). The FDA wants us to remember that first approvals do not always translate into products that are immediately available to the public due to either patent […]
