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 133-144 of 291 letters

ALApproval Letter
Approval Letter Other 209471 (Jan 1, 2024)
This document is a Complete Response letter from the FDA to AFT Pharmaceuticals, Ltd. regarding New Drug Application (NDA) 209471 for COMBOGESIC. The FDA has determined that the application cannot be approved in its present form due to various deficiencies across clinical, statistical, nonclinical, product quality, and facility inspection areas. The letter outlines specific requirements for revising labeling, providing safety updates, addressing data quality issues, justifying drug substance specifications, analyzing elemental impurities, and confirming process validation. It also details the process and timeline for resubmission or other actions.
IssuedJan 1, 2024
US FDA• COMBOGESIC (ibuprofen 97.5 mg/acetaminophen 325 mg) Film-Coated Tablets
ALApproval Letter
Approval Letter Other 210136 (Jan 1, 2024)
This is a Complete Response letter from the FDA to Braeburn Inc. for their New Drug Application (NDA) 210136 for BRIXADI (buprenorphine) extended-release injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, prescribing information, proprietary name resubmission, safety update requirements, and mandated postmarketing studies.
IssuedJan 1, 2024
US FDA• BRIXADI (buprenorphine) extended-release injection for subcutaneous use
ALApproval Letter
Approval Letter Other 210852 (Jan 1, 2024)
The FDA issued a Complete Response letter for New Drug Application (NDA) 210852 for Cyclophosphamide Injection, indicating that the application cannot be approved in its current form due to deficiencies related to facility inspections and requiring a comprehensive safety update.
IssuedJan 1, 2024
US FDA• Cyclophosphamide Injection, 500mg/mL, 1g/2mL, and 2g/4mL
ALApproval Letter
Approval Letter Other 211566 (Jan 1, 2024)
This document contains two FDA letters concerning NDA 211566 for Sitagliptin Tablets. The first letter, dated March 3, 2023, details extensive requirements for updating safety data in a resubmission, including incorporating new clinical trial data, comparing adverse event frequencies, providing worldwide safety experience, and translating foreign labeling. It mandates resubmission or other actions within one year. The second letter, dated September 2, 2021, grants tentative approval for Sitagliptin Tablets for type 2 diabetes, contingent on the resolution of patent protection and exclusivity issues, specifically a patent infringement suit related to a Paragraph IV certification. It outlines the conditions for lifting the 30-month stay and the process for requesting final approval, which includes a safety update and confirmation of any changes to the application's conditions.
IssuedJan 1, 2024
US FDA• Sitagliptin Tablets
ALApproval Letter
Approval Letter Other 211413 (Jan 1, 2024)
The FDA issued a Complete Response letter for NDA 211413 for Cefazolin for Injection USP, indicating non-approval due to deficiencies primarily related to the inadequate safety qualification of identified leachables and incomplete safety updates. The letter provides specific recommendations for addressing these issues and outlines the process for resubmission or further action.
IssuedJan 1, 2024
US FDA• Cefazolin for Injection USP, 2 g/vial
ALApproval Letter
Approval Letter Other 212905 (Jan 1, 2024)
This document is a Complete Response Letter (CRL) from the FDA to Verrica Pharmaceuticals Inc. for New Drug Application (NDA) 212905, indicating that the application for cantharidin topical solution, 7% cannot be approved in its present form. It outlines specific deficiencies and provides detailed instructions for resubmission, focusing on updated labeling, proprietary name resubmission, and a comprehensive safety update.
IssuedJan 1, 2024
US FDA• cantharidin topical solution, 7%
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 213931 (Jan 1, 2024)
This is a Complete Response Letter from the FDA to Ardelyx, Inc. regarding their New Drug Application (NDA) for tenapanor hydrochloride tablets. The FDA has determined that the application cannot be approved in its present form due to insufficient evidence of a clinically relevant treatment effect on serum phosphorus, despite acknowledging the drug's efficacy in reducing serum phosphorus. The letter outlines specific deficiencies and requirements for resubmission.
IssuedJan 1, 2024
US FDA• tenapanor hydrochloride 10 mg, 20 mg, and 30 mg tablets
ALApproval Letter
Approval Letter Other 213976 (Jan 1, 2024)
This is a Complete Response letter from the FDA to Takeda Pharmaceuticals U.S.A., Inc. for their New Drug Application (NDA) 213976 for Eohilia (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE). The FDA determined that the application cannot be approved in its current form due to insufficient evidence of effectiveness, citing deficiencies in clinical and statistical data, and provides recommendations for resolution.
IssuedJan 1, 2024
US FDA• Eohilia (budesonide oral suspension)
ALApproval Letter
Approval Letter Other 213972 (Jan 1, 2024)
The FDA issued a Complete Response letter for NDA 213972 for sulopenem etzadroxil and probenecid tablets, indicating that the application cannot be approved in its current form due to a lack of substantial evidence of effectiveness from clinical trials and other deficiencies related to labeling, barcodes, safety updates, and nonclinical PK/PD studies.
IssuedJan 1, 2024
US FDA• sulopenem etzadroxil and probenecid tablets, 500 mg/500 mg
ALApproval Letter
Approval Letter Other 214952 (Jan 1, 2024)
This document is a Complete Response letter from the FDA to CMP Development LLC regarding their New Drug Application (NDA) for sildenafil oral suspension, 10 mg/ml. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, prescribing information, proprietary name, and safety updates.
IssuedJan 1, 2024
US FDA• LIQREV (sildenafil) oral suspension, 10 mg/ml
ALApproval Letter
Approval Letter Other 215040 (Jan 1, 2024)
This is a Complete Response Letter from the FDA to Galephar Pharmaceutical Research Inc. regarding their New Drug Application (NDA) 215040 for Legubeti (acetylcysteine) for oral solution. The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to clinical data, regulatory compliance, and safety information.
IssuedJan 1, 2024
US FDA• Legubeti (acetylcysteine) for oral solution

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Approval Letter Other 209471 (Jan 1, 2024)

Approval Letter Other 210136 (Jan 1, 2024)

Approval Letter Other 210852 (Jan 1, 2024)

Approval Letter Other 211566 (Jan 1, 2024)

Approval Letter Other 211413 (Jan 1, 2024)

Approval Letter Other 212905 (Jan 1, 2024)

Approval Letter Other 212849 (Jan 1, 2024)

Approval Letter Other 213931 (Jan 1, 2024)

Approval Letter Other 213976 (Jan 1, 2024)

Approval Letter Other 213972 (Jan 1, 2024)

Approval Letter Other 214952 (Jan 1, 2024)

Approval Letter Other 215040 (Jan 1, 2024)