Generic competition is routine in tablets. It is far less routine when every dose contains a decaying isotope, must meet exacting release standards, and has to arrive at a nuclear medicine department on schedule.
On September 22, the FDA granted final approval to Lantheus's Bravnetsa, lutetium Lu 177 dotatate, through an Abbreviated New Drug Application. FDA determined it to be bioequivalent and therapeutically equivalent to Lutathera, the radioligand therapy marketed by Novartis subsidiary Advanced Accelerator Applications.
