CRMD - FDA to decide on CorMedix's DefenCath drug application by Nov. 15
2023-06-21 12:48:11 ET
CorMedix ( NASDAQ: CRMD ) said that the US Food and Drug Administration has accepted its resubmitted new drug application for DefenCath, with the agency expected to decide on whether to approve the product by Nov. 15.
The company is seeking to have DefenCath approved for the reduction of catheter-related bloodstream infections in patients receiving chronic hemodialysis via a central venous catheter.
DefenCath has received both fast track and qualified infectious disease product designations by the FDA. CorMedix also plans to study the product for pediatric use.
More on CorMedix:
- CorMedix resubmits marketing application for lead candidate DefenCath
- CorMedix receives notice of allowance for US patent application covering lead product DefenCath
For further details see:
FDA to decide on CorMedix's DefenCath drug application by Nov. 15