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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 337-348 of 493 letters

ALApproval Letter

Approval Letter Other 213645 (Jan 1, 2022)

The FDA issued a Complete Response letter for New Drug Application (NDA) 213645 for DAPZURA RT (daptomycin) for Injection, indicating that the application cannot be approved in its present form. The primary reasons for non-approval include inadequate non-clinical safety qualification for several detected leachables, deficiencies in the proposed Prescribing Information and carton/container labeling, and the need for a comprehensive safety update.

IssuedJan 1, 2022
US FDA• DAPZURA RT (daptomycin) for Injection
ALApproval Letter

Approval Letter Other 213478 (Jan 1, 2022)

This letter from the FDA addresses the New Drug Application (NDA) 213478, outlining deficiencies that prevent its approval. It provides instructions regarding labeling, proprietary name resubmission, facility inspection requirements (specifically for TOYO PHARMACEUTICAL CO. LTD. in Japan, which was delayed due to travel restrictions), and a comprehensive safety update. The applicant is required to address these deficiencies within one year, with specific guidance on resubmission and the option to request a meeting.

IssuedJan 1, 2022
US FDA• Hyftor
ALApproval Letter

Approval Letter Other 213895 (Jan 1, 2022)

This is a Complete Response Letter from the FDA to Xellia Pharmaceuticals, ApS, for their New Drug Application (NDA) 213895 for Vancomycin Injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to product quality, nonclinical toxicology, and safety updates. The letter outlines specific issues and recommendations for addressing them.

IssuedJan 1, 2022
US FDA• Vancomycin Injection, 5 g/100 mL
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 213953 (Jan 1, 2022)

The FDA issued a Complete Response Letter for New Drug Application (NDA) 213953 for testosterone undecanoate, citing that the application cannot be approved in its present form due to unreliable pharmacokinetic (PK) data from the pivotal efficacy and safety trial (MRS-TU-2019EXT). The unreliability stems from inadequate documentation of PK sample handling and processing at multiple clinical sites, which raised significant uncertainties about the integrity of the entire study's PK data.

IssuedJan 1, 2022
US FDA• testosterone undecanoate
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 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

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