FDA LETTER LIBRARY

Complete response & enforcement letters

Name: FDA Complete Response & Enforcement Letters
Creator: Assyro AI
License: https://www.usa.gov/government-works

One place to review FDA responses, identify remediation themes, and open the interactive co-pilot for every letter.

Showing 157-168 of 291 letters

ALApproval Letter
Approval Letter Other 761133 (Jan 1, 2024)
The FDA issued a Complete Response letter for Takeda Pharmaceuticals' Biologics License Application (BLA) 761133 for MLN0002 SC, indicating that the application cannot be approved in its current form due to various deficiencies. The letter details specific recommendations across product quality, human factors, labeling (device, carton, container, prescribing information, medication guide), proprietary name, and facility inspections.
IssuedJan 1, 2024
US FDA• MLN0002 SC (Entyvio prefilled pen)
ALApproval Letter
Approval Letter Other 212849 (Jan 1, 2024)
The FDA issued a Complete Response letter for NDA 212849 for Rykindo (risperidone) for extended-release injectable suspension, indicating that the application cannot be approved in its present form. The FDA identified deficiencies primarily related to clinical and clinical pharmacology concerns regarding unexplained concentration spikes and potential dose dumping, disagreeing with the applicant's root-cause analysis. Additional deficiencies include biopharmaceutics issues, pending labeling comments, and the need for a comprehensive safety update.
IssuedJan 1, 2024
US FDA• Rykindo (risperidone) for extended-release injectable suspension
ALApproval Letter
Approval Letter Other 761198 (Jan 1, 2024)
This document is a Complete Response Letter from the FDA to Bio-Thera Solutions Ltd. regarding their Biologics License Application (BLA) 761198 for BAT1706. The FDA has determined that the application cannot be approved in its present form due to various deficiencies across clinical pharmacology, product quality, labeling, and safety updates. The letter outlines specific issues and provides recommendations for addressing them.
IssuedJan 1, 2024
US FDA• BAT1706
ALApproval Letter
Approval Letter Other 761248 (Jan 1, 2024)
This letter from the FDA's Center for Drug Evaluation and Research outlines deficiencies in Biologics License Application (BLA) 761248 for Kisunla and provides detailed requirements for a resubmission. Key areas addressed include long-term safety characterization, prescribing information, carton and container labeling, proprietary name, a comprehensive safety update, and product quality specifications. The applicant is required to address all deficiencies within one year to avoid withdrawal of the application.
IssuedJan 1, 2024
US FDA• Kisunla
ALApproval Letter
Approval Letter Other 217347 (Jan 1, 2024)
This is a Complete Response letter from the FDA to Botanix SB Inc. regarding their New Drug Application (NDA) 217347 for sofpironium bromide. The FDA has determined that the application cannot be approved in its present form due to deficiencies primarily related to human factors study results and the need for a safety update.
IssuedJan 1, 2024
US FDA• sofpironium bromide
ALApproval Letter
Approval Letter Other 761275 (Jan 1, 2024)
This is a Complete Response Letter from the FDA to Fresenius Kabi USA, LLC, for their Biologics License Application (BLA) 761275 for MSB11456. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facilities, and requires a comprehensive safety update and other technical revisions before approval.
IssuedJan 1, 2024
US FDA• MSB11456
ALApproval Letter
Approval Letter Other 761299 (Jan 1, 2024)
The FDA issued a Complete Response letter for Biologics License Application (BLA) 761299 for AVT02, indicating that the application cannot be approved in its current form due to deficiencies. The letter outlines specific requirements for resubmission, including resolving facility inspection issues, updating labeling, resubmitting the proprietary name, and providing a comprehensive safety update.
IssuedJan 1, 2024
US FDA• AVT02
ALApproval Letter
Approval Letter Other 761306 (Jan 1, 2024)
This is a Complete Response Letter from the FDA to Eli Lilly and Company regarding their Biologics License Application (BLA) for lebrikizumab injection. The FDA has determined that the application cannot be approved in its present form due to unresolved product quality issues related to manufacturing facility deficiencies, data reliability concerns, and pending labeling and proprietary name reviews. The letter outlines specific deficiencies and provides recommendations for resolution, including a comprehensive safety update.
IssuedJan 1, 2024
US FDA• lebrikizumab injection
ALApproval Letter
Approval Letter Other 761225 (Jan 1, 2024)
This is a Complete Response Letter from the FDA to Hugel, Inc. regarding their Biologics License Application (BLA) for letibotulinumtoxinA injection. The FDA has determined that the application cannot be approved in its present form due to several deficiencies, including unresolved facility inspection issues, pending labeling comments, and requirements for a comprehensive safety update.
IssuedJan 1, 2024
US FDA• letibotulinumtoxinA injection
ALApproval Letter
Approval Letter Other 761343 (Jan 1, 2024)
The FDA issued a Complete Response letter for Biologics License Application (BLA) 761343 for AVT04, indicating that the application cannot be approved in its present form due to outstanding deficiencies related to facility inspections, labeling, safety updates, product quality, and microbial quality.
IssuedJan 1, 2024
US FDA• AVT04
ALApproval Letter
Approval Letter Other 761355 (Jan 1, 2024)
This is a Complete Response Letter from the FDA to Regeneron Pharmaceuticals, Inc. regarding their Biologics License Application (BLA) 761355 for Eylea HD (aflibercept) Injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies in manufacturing facilities and controls, specifically non-compliance with current good manufacturing practice (cGMP) regulations.
IssuedJan 1, 2024
US FDA• Eylea HD (aflibercept) Injection
ALApproval Letter
Approval Letter Other 761365 (Jan 1, 2024)
This letter from the FDA's Center for Drug Evaluation and Research addresses deficiencies in Biologics License Application (BLA) 761365 for IMAB362 drug product. It outlines specific requirements related to analytical methods, manufacturing, labeling, proprietary name, and a comprehensive safety update, instructing the applicant on necessary actions for potential approval.
IssuedJan 1, 2024
US FDA• IMAB362

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Approval Letter Other 761133 (Jan 1, 2024)

Approval Letter Other 212849 (Jan 1, 2024)

Approval Letter Other 761198 (Jan 1, 2024)

Approval Letter Other 761248 (Jan 1, 2024)

Approval Letter Other 217347 (Jan 1, 2024)

Approval Letter Other 761275 (Jan 1, 2024)

Approval Letter Other 761299 (Jan 1, 2024)

Approval Letter Other 761306 (Jan 1, 2024)

Approval Letter Other 761225 (Jan 1, 2024)

Approval Letter Other 761343 (Jan 1, 2024)

Approval Letter Other 761355 (Jan 1, 2024)

Approval Letter Other 761365 (Jan 1, 2024)