Issued January 1, 2024
Issued
January 1, 2024
Application
Other • 215344
Review center
Other
Stage
Final Decision
Letter type
Approval Letter
This is a Complete Response letter from the FDA to Braintree Laboratories, Inc. regarding New Drug Application (NDA) 215344 for Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride) for oral solution. The FDA has determined that the application cannot be approved in its present form due to product quality/facility inspection deficiencies, issues with prescribing information, carton and container labeling, and the need for a comprehensive safety update.
The application cannot be approved in its present form due to unresolved manufacturing facility deficiencies, inadequate prescribing information content and format, issues with carton and container labeling, the need to resubmit the proprietary name, and the requirement for a comprehensive safety update.
During a recent inspection of the manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility. Satisfactory resolution of these deficiencies is required before this application may be approved.
Recommended response: Address all manufacturing facility deficiencies identified during the inspection and provide evidence of satisfactory resolution to the agency.
Submit draft labeling that is responsive to the electronic communication dated June 1, 2022. Correct formatting errors using the SRPI checklist to ensure conformance with regulations and guidances. Submit updated content of labeling in structured product labeling (SPL) format as described at FDA.gov [21 CFR 314.50(l)(1)(i)]. Provide a highlighted or marked-up copy showing all changes, as well as a clean Word version. The proposed PI must conform to the content and format regulations found at 21 CFR 201.56(a) and (d) and 201.57.
Recommended response: Revise the Prescribing Information according to previous communications, regulatory requirements (21 CFR 201.56, 201.57, 314.50(l)(1)(i)), and format guidelines (SRPI checklist, SPL format). Ensure all changes are clearly marked and a clean version is provided.
Cited: 21 CFR 314.50(l)(1)(i), 21 CFR 201.56(a), 21 CFR 201.56(d), 21 CFR 201.57
Submit draft carton and container labeling based on your submissions received on June 3, 2022.
Recommended response: Revise and resubmit the carton and container labeling as requested.
The proposed proprietary name, Suflave, was found acceptable pending approval of the application in the current review cycle. Please resubmit the proposed proprietary name when you respond to the application deficiencies.
Recommended response: Resubmit the proprietary name as part of the complete response submission.
When responding to the deficiencies, include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b). This update must include data from all nonclinical and clinical studies, describe significant changes in the safety profile, present new and combined safety data for adverse events, provide comparative tables, retabulate reasons for premature trial discontinuation, provide case report forms and narrative summaries for deaths/serious adverse events, describe changes in common adverse events, provide updated exposure information, summarize worldwide safety experience, and include English translations of current approved foreign labeling.
Recommended response: Prepare and submit a comprehensive safety update including all requested clinical and nonclinical data, analyses, and summaries as per 21 CFR 314.50(d)(5)(vi)(b).
Cited: 21 CFR 314.50(d)(5)(vi)(b)
The application received a Complete Response due to critical manufacturing quality issues, significant deficiencies in both prescribing information and carton/container labeling, and the need for a comprehensive safety update. Administrative actions like proprietary name resubmission are also required.
Regulatory change impact: Pending sponsor mitigation plan
Approval likelihood after response: 5%
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