Issued January 1, 2023
Issued
January 1, 2023
Application
Other • 214273
Review center
Other
Stage
Final Decision
Letter type
Approval Letter
This is a Complete Response Letter from the FDA to Azurity Pharmaceuticals, Inc. for New Drug Application (NDA) 214273 for Zonisade (zonisamide) oral suspension. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, prescribing information, carton and container labeling, medication guide, proprietary name, and safety update requirements.
The application cannot be approved due to unresolved manufacturing facility inspection findings, issues with a second manufacturing facility identified during a records review, and pending labeling revisions (carton/container, Medication Guide, proprietary name) and a required comprehensive safety update.
Deficiencies were conveyed during a recent inspection of a manufacturing facility. Satisfactory resolution of these deficiencies is required before the application can be approved.
Recommended response: Address all deficiencies identified during the inspection and provide evidence of satisfactory resolution.
Issues were communicated with the L M MANUFACTURING LIMITED facility during a records review under Section 704(a)(4) of the FD&C Act. These issues must be addressed, and an FDA inspection of this facility is required before approval, which was not possible during the current review cycle due to travel restrictions. Compliance with Current Good Manufacturing Practice (CGMP) regulations must be ensured.
Recommended response: Address all identified issues at the L M MANUFACTURING LIMITED facility and await FDA inspection and assessment of findings.
Cited: Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act, Current Good Manufacturing Practice (CGMP) regulations
Submit draft carton and container labeling based on FDA's proposed revisions dated January 29, 2021.
Recommended response: Incorporate FDA's proposed revisions into the carton and container labeling and resubmit.
Add the bolded statement 'ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.' or an appropriate alternative to the carton and container labels as per 21 CFR 208.24(d).
Recommended response: Add the specified Medication Guide statement to carton and container labels as per regulation.
Cited: 21 CFR 208.24(d)
The proposed proprietary name, Zonisade, was found acceptable pending approval. It needs to be resubmitted when responding to the application deficiencies.
Recommended response: Resubmit the proprietary name along with the response to other deficiencies.
A comprehensive safety update is required as described at 21 CFR 314.50(d)(5)(vi)(b). This includes data from all nonclinical and clinical studies/trials, describing significant changes, presenting new safety data, tabulations of combined data, comparative tables of adverse event frequencies, separate tables for other indications, retabulation of trial discontinuations, case report forms/narrative summaries for deaths/serious adverse events, description of changes in common adverse events, updated exposure information, worldwide experience summary, and English translations of foreign labeling.
Recommended response: Compile and submit a comprehensive safety update as per 21 CFR 314.50(d)(5)(vi)(b), including all specified data and analyses.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
The primary issues revolve around manufacturing quality and facility compliance, compounded by pending labeling updates and a comprehensive safety data update, all of which prevent approval.
Regulatory change impact: Pending sponsor mitigation plan
Approval likelihood after response: 5%
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