Assyro AI

FDA LETTER LIBRARY

Complete response & enforcement letters

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 214375 (Jan 1, 2023)

This document is a Complete Response Letter from the FDA to Polarean Inc. regarding their New Drug Application (NDA) 214375 for Xenoview (xenon-129 hyperpolarized) for Inhalation. The FDA has determined that the application cannot be approved in its present form due to various deficiencies related to product quality (drug substance, drug product, device design, and reliability), prescribing information, carton and container labeling, proprietary name, and facility inspections. The letter outlines specific issues and provides recommendations for addressing them.

IssuedJan 1, 2023
US FDA• Xenoview (xenon-129 hyperpolarized) for Inhalation
ALApproval Letter

Approval Letter Other 214522 (Jan 1, 2023)

This letter from the FDA's Center for Drug Evaluation and Research informs the applicant of NDA 214522 about required actions following an initial review. It outlines the process for resubmission or other actions, emphasizing the need to address all deficiencies and the consequences of inaction. It also provides guidance on requesting meetings and clarifies that the drug cannot be marketed until approved.

IssuedJan 1, 2023
US FDA• Unknown
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 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 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 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 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 761183 (Jan 1, 2023)

This is a Complete Response Letter from the FDA to Provention Bio, Inc. regarding their Biologics License Application (BLA) 761183 for PRV-031. The FDA has determined that the application cannot be approved in its present form due to various deficiencies across clinical pharmacology, product quality, facility inspections, prescribing information, and safety updates. The letter outlines specific issues and provides recommendations for addressing them.

IssuedJan 1, 2023
US FDA• PRV-031
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 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

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