In an FDA announcement today titled Approved First Generic for Apokyn Injection Cartridges Requires Separately Packaged Pen (here), the Agency noted that this is the first generic approved without a delivery device. While I am aware of other FDA approvals where an off-the-shelf autoinjector was available to inject a prefilled syringe (that can be procured […]
The FDA has updated its first-generic approvals list for calendar year 2021 (here). The report is current through August 31, 2021 and lists a total of sixty-eight first-time approvals. As the FDA explains, “First generics are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product […]
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 […]
Today, OGD updated its first generic approvals list (here). So far this calendar year, OGD reports 43 first generic approvals through April 26, 2019. The FDA notes: “First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. FDA considers […]
