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Search resuls for: "CorMedix"


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Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo Acquire Licensing RightsNov 15 (Reuters) - The U.S. health regulator on Wednesday approved CorMedix's (CRMD.O) antimicrobial drug for reduction of catheter-related bloodstream infections (CRBSIs) in patients with kidney disease, allowing the company to launch its first commercial product. The company plans to ready the drug for commercialization by end of the first quarter of 2024, CorMedix CEO Joe Todisco told Reuters. DefenCath, a combination of the antimicrobial active ingredient taurolidine and blood thinner heparin, has previously been rejected twice by the U.S. Food and Drug Administration (FDA) on manufacturing concerns. Ahead of the drug approval, CorMedix said it had changed its heparin supplier and the FDA had inspected its current manufacturing facility and was comfortable with it.
Persons: Andrew Kelly, Joe Todisco, CorMedix, Christy Santhosh, Shailesh Organizations: Food and Drug Administration, FDA, REUTERS, Reuters, U.S . Food, Drug Administration, RBC, DefenCath, Thomson Locations: White Oak , Maryland, U.S, New Jersey, DefenCath, Bengaluru
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