CorMedix receives a second Complete Response Letter from the FDA for Defencath
CorMedix Inc. announced that it has received a second Complete Response Letter (CRL) from the FDA stating that the DefenCath NDA cannot be approved until deficiencies recently conveyed to the contract manufacturing organization (CMO) and the supplier of the active pharmaceutical ingredient (API) heparin during inspections are resolved to the satisfaction of FDA
There were no other deficiencies related to DefenCath cited in the CRL, and the Company expects that resolution of the site-specific compliance deficiencies will clear a pathway for FDA to approve the DefenCath NDA.
The FDA has not yet advised the CMO of the post-inspection compliance classification. The Company understands that the inspectional deficiencies at these manufacturing facilities could not be resolved prior to the PDUFA date.
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