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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 313-324 of 493 letters

ALApproval Letter

Approval Letter Other 214324 (Jan 1, 2022)

This is a Complete Response Letter from the FDA to United Therapeutics Corp. regarding their New Drug Application (NDA) 214324 for treprostinil inhalation powder. 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, 2022
US FDA• treprostinil inhalation powder
ALApproval Letter

Approval Letter Other 214012 (Jan 1, 2022)

This is a Complete Response Letter from the FDA to Novartis Pharmaceuticals Corporation regarding New Drug Application (NDA) 214012 for inclisiran injection. The FDA has determined that the application cannot be approved in its present form due to objectionable conditions noted during a review of records at a manufacturing facility and other outstanding issues.

IssuedJan 1, 2022
US FDA• inclisiran injection
ALApproval Letter

Approval Letter Other 214439 (Jan 1, 2022)

This is a Complete Response Letter from the FDA to CMP Development LLC regarding their New Drug Application (NDA) for NORLIQVA (amlodipine) Oral Solution 1 mg/mL. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, proprietary name resubmission, and required safety updates.

IssuedJan 1, 2022
US FDA• NORLIQVA (amlodipine) Oral Solution 1 mg/mL
ALApproval Letter

Approval Letter Other 214581 (Jan 1, 2022)

This is a Complete Response Letter from the FDA to Novitium Pharma LLC regarding their New Drug Application (NDA) 214581 for Hydroxychloroquine Sulfate Tablets. The FDA has determined that the application cannot be approved in its present form and outlines specific deficiencies and recommendations.

IssuedJan 1, 2022
US FDA• Hydroxychloroquine Sulfate Tablets
ALApproval Letter

Approval Letter Other 214628 (Jan 1, 2022)

This is a Complete Response letter from the FDA to Nevakar, Inc. for their New Drug Application (NDA) 214628 for Norepinephrine Bitartrate in Sodium Chloride Injection. The FDA has determined that the application cannot be approved in its present form due to unresolved facility inspection deficiencies, additional CMC deficiencies, and requirements for a comprehensive safety update.

IssuedJan 1, 2022
US FDA• Norepinephrine Bitartrate in Sodium Chloride Injection
ALApproval Letter

Approval Letter Other 215000 (Jan 1, 2022)

This document is a Complete Response letter from the FDA to Accord Healthcare, Inc. regarding their New Drug Application (NDA) 215000 for Carmustine for injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to product quality, prescribing information, and safety updates. The letter outlines specific actions required for resubmission.

IssuedJan 1, 2022
US FDA• Carmustine for injection
ALApproval Letter

Approval Letter Other 215092 (Jan 1, 2022)

This is a Complete Response letter from the FDA to Santen, Inc. regarding their New Drug Application (NDA) for Omlonti (omidenepag isopropyl ophthalmic solution), 0.002%. The FDA has determined that the application cannot be approved in its present form due to several deficiencies, including manufacturing facility issues, inadequate clinical safety data regarding corneal endothelial cell loss, and requirements related to the product's classification as a drug-led combination product. The letter outlines specific actions and information required for resubmission and potential approval.

IssuedJan 1, 2022
US FDA• Omlonti (omidenepag isopropyl ophthalmic solution), 0.002%
ALApproval Letter

Approval Letter Other 761082 (Jan 1, 2022)

The FDA issued a Complete Response Letter for Biologics License Application (BLA) 761082 for Theragrastim, indicating that the application cannot be approved in its current form due to several deficiencies, including the need for a facility inspection, issues with stability protocols and analytical methods, and requirements for labeling and safety updates.

IssuedJan 1, 2022
US FDA• Theragrastim
ALApproval Letter

Approval Letter Other 761084 (Jan 1, 2022)

This is a Complete Response Letter from the FDA to Kashiv BioSciences, LLC regarding their Biologics License Application (BLA) 761084 for TPI-120. The FDA has determined that the application cannot be approved in its present form due to various deficiencies across microbiology, labeling, facility inspections, safety data, stability, shipping validation, and immunogenicity.

IssuedJan 1, 2022
US FDA• TPI-120
ALApproval Letter

Approval Letter Other 761127 (Jan 1, 2022)

This is a Complete Response Letter from the FDA to Revance Therapeutics, Inc. regarding their Biologics License Application (BLA) 761127 for daxibotulinumtoxinA for injection. The FDA has determined that the application cannot be approved in its present form due to unresolved manufacturing facility deficiencies and pending labeling issues. The letter outlines the required actions for resubmission, including resolving manufacturing issues, revising prescribing information and carton/container labeling, resubmitting the proprietary name, and providing a comprehensive safety update.

IssuedJan 1, 2022
US FDA• daxibotulinumtoxinA for injection
ALApproval Letter

Approval Letter Other 761148 (Jan 1, 2022)

This is a Complete Response Letter from the FDA to Spectrum Pharmaceuticals, Inc. regarding their Biologics License Application (BLA) for SPI-2012. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to product quality (manufacturing facility inspections), prescribing information, carton and container labeling, proprietary name resubmission, and the need for a comprehensive safety update.

IssuedJan 1, 2022
US FDA• SPI-2012
ALApproval Letter

Approval Letter Other 761164 (Jan 1, 2022)

This is a Complete Response letter from the FDA to Bioverativ USA, Inc. regarding their Biologics License Application (BLA) for sutimlimab. The FDA has determined that the application cannot be approved in its present form and outlines specific deficiencies and recommendations that must be addressed for approval.

IssuedJan 1, 2022
US FDA• sutimlimab

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