Baxter's Generic Regadenoson Monohydrate Receives Receives Approval in the U.S.
TOKYO, May 11, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today confirmed that the Court of Appeals for the Federal Circuit (CAFC) issued a Mandate that officially ends the CAFC appeal on patent infringement of LEXISCAN® (regadenoson injection) 0.4 mg/mL.
Dr Reddy's Laboratories Ltd on Friday announced the launch of Regadenoson injection, used as an agent in the imaging of heart muscle to check blood flow, in the US market. Regadenoson injection is supplied as single-dose pre-filled syringes, 0.4mg/5ml (0.08 mg/ml). It is a generic therapeutic equivalent of Lexiscan injection, approved by US Food and Drug Administration (USFDA), Dr Reddy's said in a regulatory filing.
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It’s near the end of the game and Astellas is running out of timeouts as it tries to stave off generic competition for its scanning agent Lexiscan.
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Hospira's Generic Regadenoson Receives Approval in the U.S.
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