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The CRL also requested additional technical data on the final commercial product, which Orexo said was “unexpected.” The FDA previously rejected OX124 in April 2023, citing “technical issues with the equipment used for the secondary packaging process.” July 10 Product: Novo Nordisk’s insulin icodec Indication: Diabetes mellitus Novo Nordisk was hit with a rejection Wednesday for its once-weekly basal insulin icodec injection for the treatment of diabetes mellitus

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