Assyro AI
US FDA•United StatesAL•Approval Letter

Approval Letter Other (Nov 13, 2025)

Issued November 13, 2025

Issued

November 13, 2025

Application

Other

Review center

Other

Stage

Late Cycle

Letter type

Approval Letter

Response due November 13, 2026Product may be marketed.

Summary

The FDA issued a Complete Response letter for Azurity Pharmaceuticals, Inc.'s New Drug Application (NDA) 219122 for sitagliptin oral solution, indicating that the application cannot be approved in its current form due to outstanding deficiencies related to facility inspections, prescribing information, proprietary name, and safety updates.

Key points

  • The facility must provide satisfactory responses to deficiencies conveyed by the FDA following inspection, and these responses must be submitted to the FDA office indicated on the FDA 483.
  • The applicant must coordinate with the facility for timely resolution of inspection deficiencies.
  • The complete response must include the date(s) of the facility’s response(s) to the FDA Form 483.
  • If prescribing information is revised, the applicant must use the Selected Requirements for Prescribing Information (SRPI) checklist to ensure conformity with format items in regulations and guidances.
  • The response must include updated content of labeling in structured product labeling (SPL) format as described at FDA.gov.
  • The applicant must resubmit the proposed proprietary name (Brynovin) when responding to all application deficiencies.
  • The applicant must include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) in their response.
  • The safety update must describe in detail any significant changes or findings in the safety profile.

Cited reasons

  • Unsatisfactory Facility Inspections and CGMP Compliance
  • Proprietary Name Resubmission Pending Application Approval
  • Inadequate Clinical Safety Update and Data Presentation
  • Labeling Review Reserved Pending Application Adequacy
  • The FDA issued a Complete Response Letter for the sitagliptin oral solution NDA, citing major deficiencies related to unsatisfactory facility inspections and CGMP compliance, as well as inadequate clinical safety data updates and presentation. The proposed proprietary name requires resubmission, and labeling review is reserved pending resolution of other issues.

Recommended actions

  • The facility must provide satisfactory responses to deficiencies conveyed by the FDA following inspection, and these responses must be submitted to the FDA office indicated on the FDA 483.
  • The applicant must coordinate with the facility for timely resolution of inspection deficiencies.
  • The complete response must include the date(s) of the facility’s response(s) to the FDA Form 483.
  • If prescribing information is revised, the applicant must use the Selected Requirements for Prescribing Information (SRPI) checklist to ensure conformity with format items in regulations and guidances.
  • The response must include updated content of labeling in structured product labeling (SPL) format as described at FDA.gov.
  • The applicant must resubmit the proposed proprietary name (Brynovin) when responding to all application deficiencies.
  • The applicant must include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) in their response.
  • The safety update must describe in detail any significant changes or findings in the safety profile.

Deficiency summary

The FDA issued a Complete Response Letter for the sitagliptin oral solution NDA, citing major deficiencies related to unsatisfactory facility inspections and CGMP compliance, as well as inadequate clinical safety data updates and presentation. The proposed proprietary name requires resubmission, and labeling review is reserved pending resolution of other issues.

Findings

Unsatisfactory Facility Inspections and CGMP Compliance

Severity: critical

Deficiencies were conveyed to the facility representative following inspection. Satisfactory responses to the FDA 483 are required prior to complete response, and may require re-inspection. Satisfactory outcomes of both a Pre-Approval Inspection (PAI) and CGMP surveillance inspections are needed prior to approval. The applicant should coordinate with the facility for timely resolution.

Recommended response: Coordinate with the manufacturing facility to address all FDA 483 deficiencies, ensure CGMP compliance, and prepare for potential re-inspection and PAI to achieve satisfactory outcomes.

Proprietary Name Resubmission Pending Application Approval

Severity: minor

The proposed proprietary name, Brynovin, was found conditionally acceptable pending approval of the application. It must be resubmitted when all other application deficiencies have been identified and addressed.

Recommended response: Resubmit the proposed proprietary name, Brynovin, as part of the complete response after all other application deficiencies have been resolved.

Inadequate Clinical Safety Update and Data Presentation

Severity: major

A comprehensive safety update is required as per 21 CFR 314.50(d)(5)(vi)(b). This includes detailing significant changes in safety profile, incorporating new safety data (tabulations, comparisons), providing separate tables for adverse events in other indications, submitting case report forms and narrative summaries for deaths/discontinuations due to adverse events, providing updated exposure information, and summarizing worldwide safety experience.

Recommended response: Compile a detailed safety update, including all requested clinical data analyses, case report forms, narrative summaries for serious adverse events, updated exposure information, and a summary of worldwide safety experience, adhering strictly to 21 CFR 314.50(d)(5)(vi)(b).

Cited: 21 CFR 314.50(d)(5)(vi)(b)

Labeling Review Reserved Pending Application Adequacy

Severity: info

Comments on proposed labeling (Prescribing Information, Carton and Container Labeling) are reserved until the application is otherwise adequate. The applicant is encouraged to review labeling resources and use the SRPI checklist. Updated content of labeling in Structured Product Labeling (SPL) format is required upon resubmission.

Recommended response: Proactively review labeling guidance and resources (e.g., SRPI checklist) and prepare updated labeling in SPL format, but await resolution of other deficiencies before final submission.

Cited: 21 CFR 314.50(l)(1)(i)

Regulatory context

Submission stage
late cycle
Regulatory pathway
505(b)(2) new drug application (NDA)

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 and quality system deficiencies identified during facility inspections, and significant shortcomings in the clinical safety data update and presentation. Resolution of these core issues is prerequisite for further review of labeling and proprietary name.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 5%

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