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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 241-252 of 291 letters

ALApproval Letter

Approval Letter Other 208232 (Jan 1, 2020)

This document is an 'Other Action Letter' from the FDA regarding New Drug Application (NDA) 208232 for Mycapssa. It details significant deficiencies found in the application, particularly concerning the efficacy data from study CH-ACM-01, where the estimate of efficacy could not distinguish Mycapssa's effect from other confounding factors. The letter also outlines specific requirements for labeling, carton and container labeling, proprietary name resubmission, and a comprehensive safety update, instructing the applicant on the necessary steps for resubmission or other actions within one year.

IssuedJan 1, 2020
US FDA• Mycapssa
ALApproval Letter

Approval Letter Other 208352 (Jan 1, 2020)

The FDA issued a Complete Response letter for NDA 208352 for Amphora vaginal gel, indicating that the application cannot be approved in its present form. The decision is based on deficiencies in clinical trial data, particularly regarding the generalizability of Russian data, insufficient cycles for safety and efficacy analysis, and concerns about study conduct. Additionally, there are deficiencies related to facility inspections, device description, biocompatibility testing, bench testing, and stability/shelf life of the applicators. The letter also provides comments on prescribing information and carton/container labeling requirements.

IssuedJan 1, 2020
US FDA• Amphora (lactic acid 1.76 %, citric acid 1%, and potassium bitartrate 0.4%) vaginal gel
ALApproval Letter

Approval Letter Other 209529 (Jan 1, 2020)

The FDA issued a Complete Response letter for NDA 209529 for solifenacin succinate oral suspension, indicating that the application cannot be approved in its current form due to manufacturing facility deficiencies, inadequate control of raw material quality, and insufficient drug product specifications and stability programs regarding objectionable microorganisms. The letter outlines specific actions required for resubmission.

IssuedJan 1, 2020
US FDA• solifenacin succinate oral suspension, 1 mg/mL
ALApproval Letter

Approval Letter Other 209510 (Jan 1, 2020)

The FDA issued a Complete Response letter for New Drug Application (NDA) 209510 for Barhemsys (amisulpride) injection, indicating that the application cannot be approved in its current form. Deficiencies were identified in product quality/facility inspections, prescribing information, proprietary name, and safety update requirements. The letter outlines specific actions and data submissions required for potential approval, including resolving manufacturing issues, providing comprehensive safety data updates, and addressing labeling concerns.

IssuedJan 1, 2020
US FDA• Barhemsys (amisulpride) injection
ALApproval Letter

Approval Letter Other 209575 (Jan 1, 2020)

This document is a Complete Response letter from the FDA to Lannett Holdings, Inc. regarding their New Drug Application (NDA) 209575 for Cocaine Hydrochloride Topical Solution, 4% and 10%. The FDA has determined that the application cannot be approved in its present form due to several deficiencies in clinical, nonclinical, and regulatory aspects, and provides recommendations for addressing these issues.

IssuedJan 1, 2020
US FDA• Cocaine Hydrochloride Topical Solution, 4% and 10 %
ALApproval Letter

Approval Letter Other 210583 (Jan 1, 2020)

This document is a Complete Response Letter from the FDA to Recro Pharma Inc. regarding their New Drug Application (NDA) for Meloxicam Injection. The FDA has determined that the application cannot be approved in its current form due to clinical deficiencies related to the drug's onset of action, duration of efficacy, and inadequate safety data. The letter also outlines deficiencies in carton and container labeling, and requests a comprehensive safety update upon resubmission. The applicant is advised on the process for resubmission or other actions.

IssuedJan 1, 2020
US FDA• ANJESO (meloxicam) injection, 30 mg/mL
ALApproval Letter

Approval Letter Other 210605 (Jan 1, 2020)

The FDA issued a Complete Response letter for Mylan GmbH's New Drug Application (NDA 210605) for insulin glargine injection 100 units/mL, indicating that the application cannot be approved in its current form. Key deficiencies include unresolved objectionable conditions at the Biocon Sdn. Bhd. manufacturing facility, non-conformance of proposed Prescribing Information (PI) and Instructions for Use (IFU) with regulatory requirements, and the need for a comprehensive safety update. The letter provides detailed recommendations for addressing these issues and outlines the process for resubmission.

IssuedJan 1, 2020
US FDA• insulin glargine injection 100 units/mL
ALApproval Letter

Approval Letter Other 210875 (Jan 1, 2020)

This document is a Complete Response letter from the FDA to Sunovion Pharmaceuticals Inc. regarding their New Drug Application (NDA) 210875 for Kynmobi (apomorphine) sublingual film. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to human factors (HF) validation study, clinical pharmacology and biopharmaceutics, and safety characterization of oropharyngeal adverse events. The letter outlines specific reasons for the non-approval and provides recommendations for addressing these issues, including conducting a new HF validation study, completing a specific clinical study, and providing a comprehensive discussion and re-examination of safety data.

IssuedJan 1, 2020
US FDA• Kynmobi (apomorphine) sublingual film 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg
ALApproval Letter

Approval Letter Other 211039 (Jan 1, 2020)

The FDA issued a Complete Response letter for NDA 211039 for fluorescein sodium and benoxinate hydrochloride ophthalmic solution, indicating that the application cannot be approved in its present form due to manufacturing facility non-compliance with current good manufacturing practice (cGMP) regulations.

IssuedJan 1, 2020
US FDA• fluorescein sodium and benoxinate hydrochloride ophthalmic solution
ALApproval Letter

Approval Letter Other 211302 (Jan 1, 2020)

This is a Complete Response Letter from the FDA to Recordati Rare Diseases Inc. regarding their New Drug Application (NDA) for Cystadrops (cysteamine ophthalmic solution) 0.37%. The FDA has determined that the application cannot be approved in its present form due to manufacturing facility compliance issues, inadequate manufacturing methods and controls, unresolved data deficiencies, and pending labeling and safety update requirements.

IssuedJan 1, 2020
US FDA• Cystadrops (cysteamine ophthalmic solution) 0.37%
ALApproval Letter

Approval Letter Other 213135 (Jan 1, 2020)

This document is a Complete Response Letter from the FDA to Braintree Laboratories, Inc. regarding their New Drug Application (NDA) 213135 for SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets. The FDA has determined that the application cannot be approved in its present form due to product quality/facility inspection deficiencies, and provides recommendations for addressing these issues, including requirements for labeling, proprietary name resubmission, and a comprehensive safety update.

IssuedJan 1, 2020
US FDA• SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets
ALApproval Letter

Approval Letter Other 210730 (Jan 1, 2020)

This is a Complete Response letter from the FDA to Trevena, Inc. regarding their New Drug Application (NDA) for Oliceridine injection. The FDA has determined that the application cannot be approved in its present form due to several deficiencies identified in clinical, nonclinical, product quality, and labeling aspects.

IssuedJan 1, 2020
US FDA• Oliceridine injection, 1 mg/mL

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