Approval Letter Other (Nov 13, 2025)

Summary

The FDA issued two Complete Response letters for New Drug Application (NDA) 208574 for Romidepsin Injection, indicating that the application cannot be approved in its present form. The letters cite deficiencies related to manufacturing facilities (Teva Parenteral Medicines, Inc. and Teva Pharmaceutical Works Private Limited Company), product quality, and require comprehensive safety updates and revisions to prescribing information.

Key points

• Satisfactory resolution of product quality deficiencies identified during the inspection of TEVA PARENTERAL MEDICINES, INC. (FEI 2027158) manufacturing facility.
• Satisfactory resolution of manufacturing facility deficiencies identified during the inspection of Teva Pharmaceutical Works Private Limited Company, Gödöllő, Hungary (FEI 3002875215).
• Review and revise proposed labeling to conform with PLR Requirements for Prescribing Information and the Selected Requirements for Prescribing Information (SRPI) checklist.
• Include updated content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format.
• Provide a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
• The safety update must describe in detail any significant changes or findings in the safety profile.
• The safety update must present new safety data from studies/clinical trials for the proposed indication using the same format as in the original submission.
• The safety update must present tabulations of the new safety data combined with the original application data.

Cited reasons

• Unresolved Manufacturing Facility Inspection Deficiencies
• Inadequate and Incomplete Safety Update
• Labeling Review Deferred Pending Other Deficiencies
• The application cannot be approved in its present form due to unresolved manufacturing facility inspection deficiencies and an inadequate safety update. The agency has reserved comments on labeling until other issues are resolved.

Recommended actions

• Satisfactory resolution of product quality deficiencies identified during the inspection of TEVA PARENTERAL MEDICINES, INC. (FEI 2027158) manufacturing facility.
• Satisfactory resolution of manufacturing facility deficiencies identified during the inspection of Teva Pharmaceutical Works Private Limited Company, Gödöllő, Hungary (FEI 3002875215).
• Review and revise proposed labeling to conform with PLR Requirements for Prescribing Information and the Selected Requirements for Prescribing Information (SRPI) checklist.
• Include updated content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format.
• Provide a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
• The safety update must describe in detail any significant changes or findings in the safety profile.
• The safety update must present new safety data from studies/clinical trials for the proposed indication using the same format as in the original submission.
• The safety update must present tabulations of the new safety data combined with the original application data.

Deficiency summary

The application cannot be approved in its present form due to unresolved manufacturing facility inspection deficiencies and an inadequate safety update. The agency has reserved comments on labeling until other issues are resolved.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

505(b)(2)

Impact

Impact score

0.95

Estimated delay

545 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The primary themes for this Complete Response are critical manufacturing quality issues identified during facility inspection and significant gaps in the provided safety update, requiring comprehensive data submission and analysis.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 5%