Without much fanfare, on November 11, 2019, OGD approved the first generic vaginal contraceptive ring. Amneal’s approval showed up today on the Drug@FDA, FDA approved drugs list. It is a therapeutic equivalent to Nuvaring by Organon/Merck. Given the ANDA number, it appears that the application was submitted about early to mid-2018, which by all standards […]
Tomorrow, the FDA will issue a final rule (see prepublication document here) very similar to its proposed rule published in the Federal Register on September 12, 2018. The notice states “[I]n this final rule, FDA repeals the irradiation regulation, which provided that any drug sterilized by irradiation was a new drug. OTC drugs marketed pursuant to […]
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 […]
Dr Sally Choe, Director, Office of Generic Drugs, outlined the actions that OGD has taken for outreach to stakeholders, citing the many workshops and seminars in which OGD participated. She provided a view of the GDUFA regulatory science initiatives, including guidance on complex products, internal alignment on complex issues, confidence in generic substitution, review tool […]
