Issued January 1, 2020
Issued
January 1, 2020
Application
Other • 213135
Review center
Other
Stage
Final Decision
Letter type
Approval Letter
This document is a Complete Response Letter from the FDA to Braintree Laboratories, Inc. regarding their New Drug Application (NDA) 213135 for SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets. The FDA has determined that the application cannot be approved in its present form due to product quality/facility inspection deficiencies, and provides recommendations for addressing these issues, including requirements for labeling, proprietary name resubmission, and a comprehensive safety update.
The New Drug Application for SUTAB tablets cannot be approved in its present form due to unresolved manufacturing facility deficiencies, inadequate prescribing information and SPL format, outstanding carton and container labeling, the need for proprietary name resubmission, and an incomplete safety update requiring extensive data and specific presentation formats.
During a recent inspection of the Braintree Laboratories, Inc. manufacturing facility, field investigators conveyed deficiencies. Satisfactory resolution of these deficiencies is required before this NDA may be approved.
Recommended response: Address and resolve all deficiencies identified during the manufacturing facility inspection to ensure compliance with Good Manufacturing Practices (GMP).
The proposed labeling is not yet adequate. If revised, it must conform with format items in regulations and guidances, and the response must include updated content of labeling in structured product labeling (SPL) format.
Recommended response: Review and revise prescribing information to ensure compliance with PLR requirements, Pregnancy and Lactation Labeling Final Rule, and SRPI checklist. Submit updated content in SPL format.
Cited: 21 CFR 314.50(l)(1)(i)
Submit draft carton and container labeling based on previously submitted display panels (March 3, 2020) and the kit carton layout (March 11, 2020).
Recommended response: Prepare and submit draft carton and container labeling as requested, incorporating previous submissions.
The proposed proprietary name, SUTAB, was found acceptable pending approval of the application. It needs to be resubmitted when responding to the application deficiencies.
Recommended response: Resubmit the proposed proprietary name, SUTAB, with the complete response.
A comprehensive safety update is required as described in 21 CFR 314.50(d)(5)(vi)(b). This includes detailed changes in safety profile, incorporation of new safety data (tabulated with original data and comparative tables), separate tables for other indications, retabulation of premature trial discontinuations, case report forms and narrative summaries for deaths/serious adverse events, information on changes in common adverse events, updated exposure information, worldwide safety experience summary, and English translations of foreign labeling.
Recommended response: Compile and submit a comprehensive safety update addressing all specified data requirements, including new data, comparative analyses, case reports, and worldwide experience, formatted as requested.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
The application received a Complete Response Letter primarily due to critical manufacturing facility deficiencies and significant outstanding issues related to the comprehensive safety data update. Additional administrative and labeling updates are also required.
Regulatory change impact: Pending sponsor mitigation plan
Approval likelihood after response: 5%
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