CorMedix To Resubmit NDA For DefenCath; CMS Says DefenCath Meets Criteria For NTAP Inclusion

(RTTNews) - CorMedix Inc. (CRMD) said, following Type A meeting with the FDA, the company plans to resubmit its NDA for DefenCath by the middle of May. Based on guidance from FDA, CorMedix will resubmit the NDA with manufacturing data generated at CMO 1 and utilizing both the existing source of heparin API as well as a new supplier of Heparin API. As the submission will contain new manufacturing information, the company expects it to be classified as a class 2 resubmission with a 6-month review.

Also, CorMedix announced that following the submission of a duplicate New Technology Add-On Payment application in fourth quarter to the Centers for Medicare & Medicaid Services, CMS has subsequently issued the Inpatient Prospective Payment System 2024 proposed rule that includes a NTAP of up to $17,111 per hospital stay for DefenCath. The NTAP is conditioned upon the DefenCath NDA obtaining final FDA approval prior to July 1, 2024.

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