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 181-192 of 291 letters

ALApproval Letter
Approval Letter Other 214520 (Jan 1, 2023)
The FDA issued a Complete Response Letter for CorMedix Inc.'s New Drug Application (NDA) 214520 for taurolidine/heparin catheter lock solution. The application cannot be approved in its current form due to deficiencies related to product quality/facility inspections, prescribing information, carton/container labeling, and the proposed proprietary name. The letter outlines specific requirements and recommendations for addressing these issues in a resubmission.
IssuedJan 1, 2023
US FDA• Defencath (taurolidine 67.5 mg/5 mL (13.5 mg/mL) and heparin 5,000 USP Units/5 mL (1,000 Units/mL)) catheter lock solution
ALApproval Letter
Approval Letter Other 214860 (Jan 1, 2023)
This is a Complete Response letter from the FDA to Acer Therapeutics Inc. regarding their New Drug Application (NDA) 214860 for sodium phenylbutyrate. The FDA has determined that the application cannot be approved in its current form due to several deficiencies, including an incomplete facility inspection, issues with prescribing information and labeling, and requirements for a safety update and additional nonclinical data.
IssuedJan 1, 2023
US FDA• sodium phenylbutyrate
ALApproval Letter
Approval Letter Other 215352 (Jan 1, 2023)
This document is an 'Other Action Letter' from the FDA regarding NDA 215352. It outlines deficiencies and provides guidance on various aspects including human factors validation, prescribing information, carton and container labeling, proprietary name, and safety updates. It also specifies the actions required for resubmission and the timeline for response.
IssuedJan 1, 2023
US FDA• MYDCOMBI
ALApproval Letter
Approval Letter Other 215559 (Jan 1, 2023)
The FDA issued a Complete Response letter for NDA 215559 for palovarotene capsules, indicating that the application cannot be approved in its current form due to inadequate support for efficacy. The letter outlines major unresolved review issues, primarily concerning the efficacy data and analysis methods, and provides detailed recommendations for additional data and analyses required for resubmission.
IssuedJan 1, 2023
US FDA• palovarotene capsules
ALApproval Letter
Approval Letter Other 216686 (Jan 1, 2023)
This is a Complete Response letter from the FDA to Spes Pharmaceuticals Inc. regarding their New Drug Application (NDA) 216686 for fosaprepitant injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies identified in product quality/facility inspections, prescribing information, carton and container labeling, and clinical safety data.
IssuedJan 1, 2023
US FDA• fosaprepitant injection, 150 mg/50 mL (3 mg/mL)
ALApproval Letter
Approval Letter Other 761151 (Jan 1, 2023)
This is a Complete Response letter from the FDA to UCB, Inc. regarding their Biologics License Application (BLA) 761151 for UCB4940 (CDP4940). The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections and product quality. The letter outlines specific requirements for resubmission, including resolving facility inspection deficiencies, resubmitting the proprietary name, and providing a comprehensive safety update.
IssuedJan 1, 2023
US FDA• UCB4940 (CDP4940)
ALApproval Letter
Approval Letter Other 761161 (Jan 1, 2023)
This document is a Complete Response Letter from the FDA to Chiesi USA regarding their Biologics License Application (BLA) 761161 for PRX-102. The FDA has determined that the application cannot be approved in its present form due to several deficiencies, including issues with manufacturing facilities, questions regarding the accelerated approval pathway given the availability of other therapies, non-conformity of proposed Prescribing Information, and requirements for a comprehensive safety update. The letter also notes that an inspection of a manufacturing facility is required but was not possible due to travel restrictions.
IssuedJan 1, 2023
US FDA• PRX-102
ALApproval Letter
Approval Letter Other 761219 (Jan 1, 2023)
This document is an 'Other Action Letter' from the FDA regarding Biosimilar License Application (BLA) 761219. It outlines deficiencies related to prescribing information, carton and container labeling, proprietary name, and safety updates, and also includes specific requirements for device testing. The letter instructs the applicant on necessary actions for resubmission to achieve approval.
IssuedJan 1, 2023
US FDA• Yuflyma
ALApproval Letter
Approval Letter Other 761184 (Jan 1, 2023)
The FDA issued a Complete Response letter for Biologic License Application (BLA) 761184 for MOD-4023 injection, indicating that the application cannot be approved in its present form. The primary reasons for non-approval include concerns regarding immunogenicity, specifically high rates of anti-drug antibody (ADA) formation and potential for cross-reactivity with other human growth hormone (hGH) products, which could lead to attenuation of effectiveness and non-responsiveness to other therapies. The FDA also noted that required facility inspections could not be completed due to travel restrictions. The letter outlines specific recommendations and requirements for the applicant to address these deficiencies.
IssuedJan 1, 2023
US FDA• MOD-4023 injection
ALApproval Letter
Approval Letter Other 761240 (Jan 1, 2023)
The FDA issued a Complete Response Letter for Biologics License Application (BLA) 761240 for toripalimab-tpzi injection, indicating that the application cannot be approved in its current form due to deficiencies primarily related to product quality (viral safety), labeling, and safety update requirements.
IssuedJan 1, 2023
US FDA• toripalimab-tpzi injection
ALApproval Letter
Approval Letter Other 761192 (Jan 1, 2023)
This is a Complete Response Letter from the FDA to MediWound, Ltd. regarding their Biologics License Application (BLA) 761192 for 'concentrate of proteolytic enzymes enriched in bromelain' gel. The FDA has determined that the application cannot be approved in its present form due to various deficiencies related to product quality, clinical study data integrity, and safety information.
IssuedJan 1, 2023
US FDA• NexoBrid (concentrate of proteolytic enzymes enriched in bromelain gel)
ALApproval Letter
Approval Letter Other 761279 (Jan 1, 2023)
This is a Complete Response Letter from the FDA to Eli Lilly and Company regarding their Biologics License Application (BLA) 761279 for LY3074828 injection for ulcerative colitis. The FDA has determined that the application cannot be approved in its current form due to deficiencies related to facility inspections, prescribing information, and the need for a comprehensive safety update.
IssuedJan 1, 2023
US FDA• LY3074828 injection

Page 16 of 25

1…14 15 16 17 18…25

Approval Letter Other 214520 (Jan 1, 2023)

Approval Letter Other 214860 (Jan 1, 2023)

Approval Letter Other 215352 (Jan 1, 2023)

Approval Letter Other 215559 (Jan 1, 2023)

Approval Letter Other 216686 (Jan 1, 2023)

Approval Letter Other 761151 (Jan 1, 2023)

Approval Letter Other 761161 (Jan 1, 2023)

Approval Letter Other 761219 (Jan 1, 2023)

Approval Letter Other 761184 (Jan 1, 2023)

Approval Letter Other 761240 (Jan 1, 2023)

Approval Letter Other 761192 (Jan 1, 2023)

Approval Letter Other 761279 (Jan 1, 2023)