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 229-240 of 291 letters

ALApproval Letter
Approval Letter Other 210864 (Jan 1, 2021)
This is a Complete Response letter from the FDA to Sedor Pharmaceuticals, LLC regarding their New Drug Application (NDA) 210864 for Sesquient (fosphenytoin sodium) injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to product quality (specifically, foreign particles), regulatory issues (reliance on reference listed drugs and Paragraph IV certifications), and requirements for prescribing information, carton/container labeling, proprietary name resubmission, and a comprehensive safety update. The letter outlines specific actions and information required for a complete response and resubmission.
IssuedJan 1, 2021
US FDA• Sesquient (fosphenytoin sodium) injection, 100 mg and 500 mg phenytoin sodium equivalents/ml
ALApproval Letter
Approval Letter Other 212045 (Jan 1, 2021)
This is a Complete Response letter from the FDA to Hikma Pharmaceuticals USA Inc. regarding their New Drug Application (NDA) for naloxone nasal spray, 8 mg. The FDA has determined that the application cannot be approved in its present form due to various deficiencies identified in product quality, manufacturing, and device-related aspects.
IssuedJan 1, 2021
US FDA• naloxone nasal spray, 8 mg
ALApproval Letter
Approval Letter Other 212122 (Jan 1, 2021)
This letter from the FDA's Center for Drug Evaluation and Research outlines deficiencies in New Drug Application (NDA) 212122 for Breztri Aerosphere and provides detailed instructions for its resubmission. The deficiencies primarily concern efficacy data, labeling, proprietary name resubmission, and a comprehensive safety update.
IssuedJan 1, 2021
US FDA• Breztri Aerosphere
ALApproval Letter
Approval Letter Other 212156 (Jan 1, 2021)
This is a Complete Response letter from the FDA to Par Sterile Products, LLC, informing them that their New Drug Application (NDA) for Micafungin for Injection cannot be approved in its current form. The letter outlines specific deficiencies across product quality, nonclinical studies, labeling, safety updates, and facility inspections that must be addressed before approval.
IssuedJan 1, 2021
US FDA• Micafungin for Injection, 50 mg/vial and 100 mg/vial
ALApproval Letter
Approval Letter Other 212501 (Jan 1, 2021)
This is a Complete Response letter from the FDA to Ingenus Pharmaceuticals, LLC regarding their New Drug Application (NDA) for Cyclophosphamide Injection. The FDA has determined that the application cannot be approved in its current form due to deficiencies related to facility inspections, prescribing information, carton and container labeling, and the need for a safety update.
IssuedJan 1, 2021
US FDA• Cyclophosphamide Injection, 500 mg/2.5 mL and 1 g/5 mL
ALApproval Letter
Approval Letter Other 213072 (Jan 1, 2021)
This is a Complete Response Letter from the FDA to Althera Life Sciences, LLC, for their New Drug Application (NDA) 213072 for rosuvastatin and ezetimibe tablet. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to product quality, facility inspections, and pediatric assessment requirements.
IssuedJan 1, 2021
US FDA• rosuvastatin and ezetimibe tablet
ALApproval Letter
Approval Letter Other 211964 (Jan 1, 2021)
The FDA issued a Complete Response Letter for NDA 211964 for viloxazine hydrochloride extended-release capsules, indicating that the application cannot be approved in its present form due to objectionable conditions at a manufacturing facility, issues with prescribing information, carton and container labeling, and the need to add a Medication Guide statement.
IssuedJan 1, 2021
US FDA• viloxazine hydrochloride extended-release capsules
ALApproval Letter
Approval Letter Other 214429 (Jan 1, 2021)
The FDA issued a Complete Response letter for NDA 214429 for Fexinidazole tablets, indicating that the application cannot be approved in its current form due to deficiencies primarily related to product labeling and the need for an updated safety profile.
IssuedJan 1, 2021
US FDA• Fexinidazole tablets, 600 mg
ALApproval Letter
Approval Letter Other 761166 (Jan 1, 2021)
This is a Complete Response Letter from the FDA to PharmaEssentia Corporation regarding Biologics License Application (BLA) 761166 for P1101, indicating that the application cannot be approved in its current form due to several deficiencies.
IssuedJan 1, 2021
US FDA• P1101
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%

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Approval Letter Other 210864 (Jan 1, 2021)

Approval Letter Other 212045 (Jan 1, 2021)

Approval Letter Other 212122 (Jan 1, 2021)

Approval Letter Other 212156 (Jan 1, 2021)

Approval Letter Other 212501 (Jan 1, 2021)

Approval Letter Other 213072 (Jan 1, 2021)

Approval Letter Other 211964 (Jan 1, 2021)

Approval Letter Other 214429 (Jan 1, 2021)

Approval Letter Other 761166 (Jan 1, 2021)

Approval Letter Other 201110 (Jan 1, 2020)

Approval Letter Other 204017 (Jan 1, 2020)

Approval Letter Other 206966 (Jan 1, 2020)