Posted by Michael Wonder on 02 Nov 2024
Alvotech and Teva announce US FDA approval of additional presentation of Selarsdi (ustekinumab-aekn), expanding its label to include further indications approved for reference product, Stelara (ustekinumab)
22 October 2024 - Approval of Selarsdi 130 mg/26 mL in a single dose vial for intravenous infusion expands label to include treatment of adults with Crohn’s disease and ulcerative colitis.
Alvotech and Teva Pharmaceuticals today announced that the US FDA has approved Selarsdi (ustekinumab-aekn) in a new presentation, 130 mg/26 mL (5 mg/mL) solution in a single dose vial for intravenous infusion. This approval paves the way for Selarsdi to further align its label with the indications of the reference product Stelara (ustekinumab) in the US at launch, which is expected in the first quarter of 2025.
