FDA Rejects Changes to Natpara Cartridge, Delaying Its Relaunch
The U.S. Food and Drug Administration (FDA) has rejected Takeda Pharmaceutical’s proposed changes to address the risk of rubber fragments detaching into Natpara’s cartridge that led to the therapy’s U.S. recall in 2019. This treatment for hypoparathyroidism involves puncturing the medication’s cartridge rubber septum — a disk…