Approval Letter Other 210895 (Jan 1, 2019)

Summary

This is a Complete Response letter from the FDA to Daiichi Sankyo Inc. regarding New Drug Application (NDA) 210895 for Welchol (colesevelam) chewable bar. The FDA has determined that the application cannot be approved in its present form due to product quality deficiencies related to manufacturing, and reserves comment on proposed labeling. The letter outlines specific actions required for resubmission.

Key points

• Satisfactorily resolve deficiencies identified during the inspection of the drug product manufacturing facility.
• Review labeling review resources on PLR Requirements for Prescribing Information and Pregnancy and Lactation Labeling Final Rule websites.
• Use the Selected Requirements for Prescribing Information (SRPI) checklist to ensure prescribing information conforms with format items in regulations and guidances if labeling is revised.
• Include updated content of labeling in structured product labeling (SPL) format as part of the response.
• Resubmit the proposed proprietary name, Welchol, when responding to the application deficiencies.
• Provide 24-month stability data for the six registration batches in the resubmission.
• Provide all available stability data for the six demonstration batches in the resubmission.
• Resubmit the application or take other available actions under 21 CFR 314.110 within one year after the date of this letter.

Cited reasons

• Unresolved Drug Product Manufacturing Facility Deficiencies
• Inadequate Prescribing Information and SPL Format
• Proprietary Name Resubmission Required
• Request for Additional Stability Data
• The application cannot be approved in its present form due to unresolved deficiencies from a drug product manufacturing facility inspection, and issues with prescribing information and proprietary name resubmission. Additional stability data is also requested for the resubmission.

Recommended actions

• Satisfactorily resolve deficiencies identified during the inspection of the drug product manufacturing facility.
• Review labeling review resources on PLR Requirements for Prescribing Information and Pregnancy and Lactation Labeling Final Rule websites.
• Use the Selected Requirements for Prescribing Information (SRPI) checklist to ensure prescribing information conforms with format items in regulations and guidances if labeling is revised.
• Include updated content of labeling in structured product labeling (SPL) format as part of the response.
• Resubmit the proposed proprietary name, Welchol, when responding to the application deficiencies.
• Provide 24-month stability data for the six registration batches in the resubmission.
• Provide all available stability data for the six demonstration batches in the resubmission.
• Resubmit the application or take other available actions under 21 CFR 314.110 within one year after the date of this letter.

Deficiency summary

The application cannot be approved in its present form due to unresolved deficiencies from a drug product manufacturing facility inspection, and issues with prescribing information and proprietary name resubmission. Additional stability data is also requested for the resubmission.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

NDA 505(b)

Impact

Impact score

0.95

Estimated delay

365 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The primary issues preventing approval are unresolved manufacturing facility deficiencies and the need for updated labeling in SPL format. The proprietary name, though previously acceptable, must be resubmitted with the complete response, and additional stability data is requested.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 5%