Approval Letter Other (Nov 13, 2025)

Summary

The document comprises multiple "Complete Response" letters from the FDA to Sun Pharma regarding New Drug Application (NDA) 204417 for Elepsia XR (levetiracetam) extended-release tablets. The letters consistently state that the application cannot be approved in its current form due to unresolved manufacturing facility deficiencies, issues with prescribing information (dosing, format, and content), and, in an earlier letter, concerns regarding bioequivalence data in the fed state and the similarity of plasma concentration-time curves compared to the reference listed drug.

Key points

• Satisfactorily resolve all deficiencies identified during inspections of the manufacturing facilities (Sun Pharmaceutical Industries, Limited).
• Address issues related to dosing information in the ELEPSIA XR labeling.
• Submit revised draft labeling that incorporates proposed changes and aligns with current regulatory requirements and innovator labeling where applicable.
• Provide updated content of labeling in Structured Product Labeling (SPL) format, adhering to 21 CFR 314.50(l)(1)(i).
• Ensure prescribing information conforms to format items in regulations and guidances, utilizing resources like the SRPI checklist.
• Address concerns regarding bioequivalence data in the fed state, demonstrating similarity of individual plasma concentration-time profiles to the Reference Listed Drug (Keppra XR).
• Resubmit the application or take other actions available under 21 CFR 314.110 within one year from the date of the letter.
• Ensure any resubmission fully addresses all listed deficiencies.

Cited reasons

• Unresolved Manufacturing Facility Deficiencies
• Inadequate Prescribing Information
• The New Drug Application for Elepsia XR cannot be approved due to persistent, unresolved manufacturing facility deficiencies and inadequate prescribing information, specifically regarding dosing. The agency requires satisfactory resolution of manufacturing issues and comprehensive revisions to the labeling to align with regulatory requirements.

Recommended actions

• Satisfactorily resolve all deficiencies identified during inspections of the manufacturing facilities (Sun Pharmaceutical Industries, Limited).
• Address issues related to dosing information in the ELEPSIA XR labeling.
• Submit revised draft labeling that incorporates proposed changes and aligns with current regulatory requirements and innovator labeling where applicable.
• Provide updated content of labeling in Structured Product Labeling (SPL) format, adhering to 21 CFR 314.50(l)(1)(i).
• Ensure prescribing information conforms to format items in regulations and guidances, utilizing resources like the SRPI checklist.
• Address concerns regarding bioequivalence data in the fed state, demonstrating similarity of individual plasma concentration-time profiles to the Reference Listed Drug (Keppra XR).
• Resubmit the application or take other actions available under 21 CFR 314.110 within one year from the date of the letter.
• Ensure any resubmission fully addresses all listed deficiencies.

Deficiency summary

The New Drug Application for Elepsia XR cannot be approved due to persistent, unresolved manufacturing facility deficiencies and inadequate prescribing information, specifically regarding dosing. The agency requires satisfactory resolution of manufacturing issues and comprehensive revisions to the labeling to align with regulatory requirements.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

505(b)(2)

Impact

Impact score

0.95

Estimated delay

365 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The application faces significant hurdles due to ongoing manufacturing quality control issues and deficiencies in the proposed product labeling, necessitating a complete re-evaluation and resolution of these critical areas before approval can be considered.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 5%