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 361-372 of 493 letters

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 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 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 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 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 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 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 202049 (Jan 1, 2021)

The FDA issued two Complete Response letters for New Drug Application (NDA) 202049 for mannitol inhalation powder, indicating that the application cannot be approved in its current form. The first letter (Chiesi USA, Inc.) cited deficiencies in human factors (HF) validation studies for the Mannitol Tolerance Test (MTT), highlighting use errors and safety concerns regarding bronchospasm. The second letter (Pharmaxis Ltd.) identified an unfavorable benefit-risk balance for inhaled mannitol in cystic fibrosis patients, citing inadequate clinical efficacy data from trials and a high occurrence of hemoptysis. Both letters outline specific deficiencies, provide recommendations for resolution, and detail requirements for resubmission, including comprehensive safety updates and adherence to labeling guidelines.

IssuedJan 1, 2021
US FDA• mannitol inhalation powder, 40 mg
ALApproval Letter

Approval Letter Other 204957 (Jan 1, 2021)

This document is a Complete Response letter from the FDA to B. Braun Medical, Inc. for New Drug Application (NDA) 204957 for Acetaminophen Injection. The application cannot be approved in its current form due to unresolved facility inspection deficiencies, pending labeling review, outstanding regulatory issues (including Mallinckrodt letters and Paragraph IV certification), and concerns regarding leachables and an unknown compound. The letter details requirements for a comprehensive safety update and outlines the process for resubmission.

IssuedJan 1, 2021
US FDA• Acetaminophen Injection in the PAB Container, 500 mg/50 mL and 1000 mg/100 mL
ALApproval Letter

Approval Letter Other 206610 (Jan 1, 2021)

This document is a Complete Response letter from the FDA to Mylan Laboratories Limited regarding their New Drug Application (NDA) 206610 for Acetaminophen for Injection, 1 g/vial. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, regulatory requirements (patent certifications), prescribing information, and safety update requirements.

IssuedJan 1, 2021
US FDA• Acetaminophen for Injection, 1 g/vial

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