Approval Letter Other 213478 (Jan 1, 2022)

Summary

This letter from the FDA addresses the New Drug Application (NDA) 213478, outlining deficiencies that prevent its approval. It provides instructions regarding labeling, proprietary name resubmission, facility inspection requirements (specifically for TOYO PHARMACEUTICAL CO. LTD. in Japan, which was delayed due to travel restrictions), and a comprehensive safety update. The applicant is required to address these deficiencies within one year, with specific guidance on resubmission and the option to request a meeting.

Key points

• Review labeling review resources on PLR Requirements for Prescribing Information and Pregnancy and Lactation Labeling Final Rule websites.
• Use the SRPI checklist to ensure Prescribing Information conforms with format items in regulations and guidances if labeling is revised.
• Include updated content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format.
• Resubmit the proposed proprietary name, Hyftor, when responding to application deficiencies.
• Address deficiencies in this Complete Response Letter while travel restrictions remain in effect.
• Ensure the required FDA inspection of TOYO PHARMACEUTICAL CO. LTD. facility (FEI 3016419927) is conducted and findings assessed before application approval.
• Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
• Describe in detail any significant changes or findings in the safety profile.

Cited reasons

• Outstanding Manufacturing Facility Inspection
• Updated Content of Labeling Required
• Proprietary Name Resubmission
• Comprehensive Safety Update Required
• English Translations of Foreign Labeling
• The application received a Complete Response Letter primarily due to an outstanding manufacturing facility inspection that could not be conducted due to travel restrictions. Additionally, the agency requires a comprehensive safety update with specific data analyses and documentation, updates to the proposed labeling in SPL format, and resubmission of the proprietary name.

Recommended actions

• Review labeling review resources on PLR Requirements for Prescribing Information and Pregnancy and Lactation Labeling Final Rule websites.
• Use the SRPI checklist to ensure Prescribing Information conforms with format items in regulations and guidances if labeling is revised.
• Include updated content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format.
• Resubmit the proposed proprietary name, Hyftor, when responding to application deficiencies.
• Address deficiencies in this Complete Response Letter while travel restrictions remain in effect.
• Ensure the required FDA inspection of TOYO PHARMACEUTICAL CO. LTD. facility (FEI 3016419927) is conducted and findings assessed before application approval.
• Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
• Describe in detail any significant changes or findings in the safety profile.

Deficiency summary

The application received a Complete Response Letter primarily due to an outstanding manufacturing facility inspection that could not be conducted due to travel restrictions. Additionally, the agency requires a comprehensive safety update with specific data analyses and documentation, updates to the proposed labeling in SPL format, and resubmission of the proprietary name.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

NDA

Impact

Impact score

0.95

Estimated delay

365 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The primary reason for the Complete Response Letter is the inability to conduct a critical manufacturing facility inspection due to external travel restrictions. Additionally, significant deficiencies exist in the clinical safety data presentation and completeness, requiring a comprehensive update, alongside standard labeling and administrative updates.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 5%