Alvotech and teva announce u.s. fda approval of additional presentation of selarsdi™ (ustekinumab-aekn), expanding its label to include further indications approved for reference product, stelara® (ustekinumab)

Reykjavik, iceland & parsippany, n.j., oct. 22, 2024 (globe newswire) -- alvotech (nasdaq: alvo) and teva pharmaceuticals, a u.s. affiliate of teva pharmaceutical industries ltd. (nyse and tase: teva), today announced that the u.s. food and drug administration (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 u.s. at launch, which is expected in the first quarter of 2025.
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