FDA Approves an Additional Presentation of SELARSDI (Ustekinumab-aekn), Aligning the Label With the Indications Approved for Reference Product, Stelara
The U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) in a new presentation, 130mg/26mL (5mg/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 U.S. at launch, which is expected in […]