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US FDA•United StatesAL•Approval Letter

Approval Letter Other 206966 (Jan 1, 2020)

Issued January 1, 2020

Issued

January 1, 2020

Application

Other • 206966

Review center

Other

Stage

Final Decision

Letter type

Approval Letter

Response due December 31, 2020Product may be marketed.

Summary

This is a Complete Response letter from the FDA to Dr. Reddy's Laboratories, SA, for their New Drug Application (NDA) 206966 for Xeglyze (abametapir) Lotion, 0.74%. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, prescribing information, proprietary name resubmission, and the need for a comprehensive safety update.

Key points

  • Satisfactorily resolve deficiencies identified during the inspection of Dr. Reddy’s Lab Ltd. CTO Unit VI manufacturing facility (FEI 3002949085).
  • Review labeling review resources on PLR Requirements for Prescribing Information and Pregnancy and Lactation Labeling Final Rule websites, including regulations and related guidance documents and the Selected Requirements for Prescribing Information (SRPI).
  • If labeling is revised, use the SRPI checklist to ensure conformity with format items in regulations and guidances.
  • Include updated content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format in the response.
  • Resubmit the proposed proprietary name, Xeglyze, when responding to the application deficiencies.
  • Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
  • The safety update must include data from all nonclinical and clinical studies/trials of the drug under consideration regardless of indication, dosage form, or dose level.
  • Describe in detail any significant changes or findings in the safety profile in the safety update.

Cited reasons

  • Unresolved Manufacturing Facility Deficiencies
  • Inadequate Prescribing Information and SPL Format
  • Resubmission of Proprietary Name
  • Incomplete Safety Update Data
  • The New Drug Application for Xeglyze (abametapir) Lotion, 0.74% cannot be approved in its current form due to unresolved manufacturing facility deficiencies, significant outstanding requirements for a comprehensive safety update, and necessary updates to prescribing information and proprietary name resubmission.

Recommended actions

  • Satisfactorily resolve deficiencies identified during the inspection of Dr. Reddy’s Lab Ltd. CTO Unit VI manufacturing facility (FEI 3002949085).
  • Review labeling review resources on PLR Requirements for Prescribing Information and Pregnancy and Lactation Labeling Final Rule websites, including regulations and related guidance documents and the Selected Requirements for Prescribing Information (SRPI).
  • If labeling is revised, use the SRPI checklist to ensure conformity with format items in regulations and guidances.
  • Include updated content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format in the response.
  • Resubmit the proposed proprietary name, Xeglyze, when responding to the application deficiencies.
  • Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
  • The safety update must include data from all nonclinical and clinical studies/trials of the drug under consideration regardless of indication, dosage form, or dose level.
  • Describe in detail any significant changes or findings in the safety profile in the safety update.

Deficiency summary

The New Drug Application for Xeglyze (abametapir) Lotion, 0.74% cannot be approved in its current form due to unresolved manufacturing facility deficiencies, significant outstanding requirements for a comprehensive safety update, and necessary updates to prescribing information and proprietary name resubmission.

Findings

Unresolved Manufacturing Facility Deficiencies

Severity: critical

Satisfactory resolution of deficiencies identified during a recent inspection of the Dr. Reddy’s Lab Ltd. CTO Unit VI (FEI 3002949085) manufacturing facility is required before this NDA may be approved.

Recommended response: Address all deficiencies identified during the manufacturing facility inspection and ensure satisfactory resolution prior to resubmission.

Inadequate Prescribing Information and SPL Format

Severity: major

Comments on proposed labeling are reserved until the application is otherwise adequate. The response must include updated content of labeling in structured product labeling (SPL) format as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.

Recommended response: Revise prescribing information to comply with PLR requirements and submit in SPL format upon resubmission, after addressing other major deficiencies.

Cited: updated content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format

Resubmission of Proprietary Name

Severity: minor

The proposed proprietary name, Xeglyze, was found acceptable pending approval of the application. It needs to be resubmitted when responding to the application deficiencies.

Recommended response: Resubmit the proprietary name with the complete response.

Incomplete Safety Update Data

Severity: major

A comprehensive safety update is required as described at 21 CFR 314.50(d)(5)(vi)(b). This includes detailed descriptions of significant changes, new safety data from all studies/trials (clinical and nonclinical), comparisons with original data, separate tables for other indications, retabulation of premature discontinuations, case report forms and narrative summaries for deaths/serious adverse events, updated exposure information, and a summary of worldwide safety experience with English translations of current approved foreign labeling.

Recommended response: Provide a comprehensive safety update incorporating all new nonclinical and clinical data, detailed analyses, case narratives, updated exposure, and worldwide experience as per regulatory requirements.

Cited: safety update as described at 21 CFR 314.50(d)(5)(vi)(b)

Regulatory context

Submission stage
final decision
Regulatory pathway
NDA 505(b)

Impact

Impact score
0.95
Estimated delay
270 days
Estimated rework cost
$0
Subsequent action
resubmission

Strategic insights

The application received a Complete Response due to critical manufacturing site deficiencies and significant outstanding requirements for a comprehensive safety update, alongside necessary administrative and labeling updates.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 5%

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