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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 397-408 of 493 letters

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 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 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 761115 (Jan 1, 2020)

This is a Complete Response Letter (CRL) from the FDA regarding Biologics License Application (BLA) 761115 for sacituzumab govitecan, indicating that the application cannot be approved in its present form due to various deficiencies related to product quality, manufacturing, labeling, facility inspections, and safety data.

IssuedJan 1, 2020
US FDA• sacituzumab govitecan powder for solution for infusion, intravenous, 180 mg
ALApproval Letter

Approval Letter Other 201110 (Jan 1, 2020)

This letter from the FDA is a Complete Response to Ferring Pharmaceuticals, Inc.'s New Drug Application (NDA) for a progesterone vaginal ring, indicating that the application cannot be approved in its present form. The letter outlines several deficiencies related to device biocompatibility, clinical safety and efficacy, prescribing information, proprietary name resubmission, and safety update requirements, providing specific recommendations for addressing these issues.

IssuedJan 1, 2020
US FDA• progesterone vaginal ring
ALApproval Letter

Approval Letter Other 204017 (Jan 1, 2020)

The FDA issued a Complete Response Letter for Agile Therapeutics, Inc.'s New Drug Application (NDA 204017) for a levonorgestrel/ethinyl estradiol transdermal contraceptive delivery system. The application cannot be approved in its current form due to significant product quality issues related to the adhesion performance of the transdermal system, deficiencies in manufacturing facility observations, and clinical concerns regarding efficacy, high Pearl Index, and high subject discontinuation rates, which may be linked to the adhesion problems. The letter outlines specific deficiencies and provides recommendations for addressing them across product quality, facility inspections, clinical data, PREA requirements, prescribing information, proprietary name, and safety updates.

IssuedJan 1, 2020
US FDA• levonorgestrel/ethinyl estradiol 120/30 mcg/day transdermal contraceptive delivery system
ALApproval Letter

Approval Letter Other 206966 (Jan 1, 2020)

This is a Complete Response letter from the FDA to Dr. Reddy's Laboratories, SA, for their New Drug Application (NDA) 206966 for Xeglyze (abametapir) Lotion, 0.74%. 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, and the need for a comprehensive safety update.

IssuedJan 1, 2020
US FDA• Xeglyze (abametapir) Lotion, 0.74%
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 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 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 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

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