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, ...
Teva Pharmaceutical Industries Limited American Depositary Shares (TEVA)
Last teva pharmaceutical industries limited american depositary shares earnings: 2/13 04:01 pm
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Source: GlobeNewswire
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 colitisThe FDA previously approved SELARSDI 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection in April 2024SELARSDI’s U.S. launch for all indications is expected in Q1 2025 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 o
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TEVA
Earnings
- 11/6/24 - Beat
TEVA
Sec Filings
- 11/21/24 - Form 4
- 11/20/24 - Form 144
- 11/12/24 - Form 8-K
- TEVA's page on the SEC website