8 August 2022 - CorMedix today announced a second complete response letter was received from the FDA stating that the DefenCath new drug application cannot be approved until deficiencies recently conveyed to the contract manufacturing organisation and the supplier of the active pharmaceutical ingredient heparin during inspections are resolved to the satisfaction of FDA.

There were no other deficiencies related to DefenCath cited in the complete response letter, and the Company expects that resolution of the site-specific compliance deficiencies will clear a pathway for FDA to approve the DefenCath new drug application.

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