CorMedix Has Meeting With FDA on DefenCath Catheter Lock Solution NDA
Wednesday, April 14, 2021, 9:00 AM ET
CorMedix Has Meeting With FDA on DefenCath Catheter Lock Solution NDA
BERKELEY HEIGHTS, N.J., April 14, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that it has met with the US Food and Drug Administration (FDA) to discuss proposed resolutions for the deficiencies identified in the Complete Response Letter (CRL) to CorMedix and the Post-Application Action Letter received by the third-party manufacturer (CMO) from FDA for the New Drug Application (NDA) for DefenCath(TM) (taurolidine/heparin catheter lock solution). Representatives from both CorMedix and the CMO participated in the meeting with FDA to ensure that there is alignment on addressing the Agency's concerns.
There is now an agreed upon protocol for the manual extraction study identified in the CRL that FDA is requiring as confirmation of in-process controls to demonstrate that the labeled volume can be consistently withdrawn from the vials. As anticipated previously, CorMedix expects to be able to complete this requirement in the next
several weeks. Addressing FDA's concerns regarding the qualification of the filling operation may necessitate adjustments in the process and generation of additional data on operating parameters for manufacture of DefenCath. CorMedix and the CMO are currently evaluating available data to determine if additional process qualification will be needed with subsequent validation to address these issues.
The FDA stated that the review timeline would be determined when the NDA resubmission is received and that it expected all corrections to facility deficiencies to be complete at the time of resubmission so that all corrective actions may be verified during an on-site evaluation in the next review cycle, if the FDA determines it will do an onsite evaluation. CorMedix and the CMO continue to work closely to ensure that the identified deficiencies are resolved prior to resubmission of the DefenCath NDA.
CorMedix will provide updates on the timeline as resolution of the deficiencies proceeds.....Problem solved!
Wednesday, April 14, 2021, 9:00 AM ET
CorMedix Has Meeting With FDA on DefenCath Catheter Lock Solution NDA
BERKELEY HEIGHTS, N.J., April 14, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that it has met with the US Food and Drug Administration (FDA) to discuss proposed resolutions for the deficiencies identified in the Complete Response Letter (CRL) to CorMedix and the Post-Application Action Letter received by the third-party manufacturer (CMO) from FDA for the New Drug Application (NDA) for DefenCath(TM) (taurolidine/heparin catheter lock solution). Representatives from both CorMedix and the CMO participated in the meeting with FDA to ensure that there is alignment on addressing the Agency's concerns.
There is now an agreed upon protocol for the manual extraction study identified in the CRL that FDA is requiring as confirmation of in-process controls to demonstrate that the labeled volume can be consistently withdrawn from the vials. As anticipated previously, CorMedix expects to be able to complete this requirement in the next
several weeks. Addressing FDA's concerns regarding the qualification of the filling operation may necessitate adjustments in the process and generation of additional data on operating parameters for manufacture of DefenCath. CorMedix and the CMO are currently evaluating available data to determine if additional process qualification will be needed with subsequent validation to address these issues.
The FDA stated that the review timeline would be determined when the NDA resubmission is received and that it expected all corrections to facility deficiencies to be complete at the time of resubmission so that all corrective actions may be verified during an on-site evaluation in the next review cycle, if the FDA determines it will do an onsite evaluation. CorMedix and the CMO continue to work closely to ensure that the identified deficiencies are resolved prior to resubmission of the DefenCath NDA.
CorMedix will provide updates on the timeline as resolution of the deficiencies proceeds.....Problem solved!
