Approval Letter Other 214520 (Jan 1, 2023)

Summary

The FDA issued a Complete Response Letter for CorMedix Inc.'s New Drug Application (NDA) 214520 for taurolidine/heparin catheter lock solution. The application cannot be approved in its current form due to deficiencies related to product quality/facility inspections, prescribing information, carton/container labeling, and the proposed proprietary name. The letter outlines specific requirements and recommendations for addressing these issues in a resubmission.

Key points

• Resolve deficiencies identified during inspections of manufacturing facilities (e.g., Rovi Pharma Industrial Services S.A.).
• Submit draft labeling responsive to a separate FDA communication upon resubmission.
• Correct formatting errors in labeling using the SRPI checklist.
• Submit updated content of labeling in Structured Product Labeling (SPL) format as described at FDA.gov (21 CFR 314.50(l)(1)(i)).
• Provide highlighted or marked-up and clean Word versions of labeling with annotations.
• Ensure proposed Prescribing Information (PI) conforms to 21 CFR 201.56(a), (d) and 201.57.
• Submit draft carton and container labeling responsive to a separate FDA communication upon resubmission.
• Submit a new request for proprietary name review for an alternate name, or indicate 'Defencath' remains the preferred name.

Cited reasons

• Manufacturing Facility Deficiencies
• Draft Prescribing Information Issues
• Draft Carton and Container Labeling Issues
• Unacceptable Proprietary Name
• The application cannot be approved in its present form due to unresolved manufacturing facility deficiencies, significant issues with draft prescribing information and carton/container labeling requiring further agency communication, and an unacceptable proposed proprietary name due to potential confusion with another product.

Recommended actions

• Resolve deficiencies identified during inspections of manufacturing facilities (e.g., Rovi Pharma Industrial Services S.A.).
• Submit draft labeling responsive to a separate FDA communication upon resubmission.
• Correct formatting errors in labeling using the SRPI checklist.
• Submit updated content of labeling in Structured Product Labeling (SPL) format as described at FDA.gov (21 CFR 314.50(l)(1)(i)).
• Provide highlighted or marked-up and clean Word versions of labeling with annotations.
• Ensure proposed Prescribing Information (PI) conforms to 21 CFR 201.56(a), (d) and 201.57.
• Submit draft carton and container labeling responsive to a separate FDA communication upon resubmission.
• Submit a new request for proprietary name review for an alternate name, or indicate 'Defencath' remains the preferred name.

Deficiency summary

The application cannot be approved in its present form due to unresolved manufacturing facility deficiencies, significant issues with draft prescribing information and carton/container labeling requiring further agency communication, and an unacceptable proposed proprietary name due to potential confusion with another product.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

NDA 505(b)

Impact

Impact score

0.95

Estimated delay

545 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The application received a Complete Response due to critical manufacturing facility issues, significant deficiencies in both prescribing information and carton/container labeling requiring further agency communication, and an unacceptable proposed proprietary name due to potential confusion with another product.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 5%