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In its Complete Response Letter (CRL), the FDA cited undisclosed product quality and master filing issues for the infusion device, which is proprietary to the device manufacturer, according to Supernus announcement
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Manufactured in a GMP Certified Facility
Intravenous therapy may cause pain at the injection site (6.5%) and local inflammation (3.1%)
Presently, no medication has gained widespread approval for MAFLD therapy
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