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 193-204 of 291 letters

ALApproval Letter
Approval Letter Other 761192 (Jan 1, 2023)
This is a Complete Response Letter from the FDA to MediWound, Ltd. regarding their Biologics License Application (BLA) 761192 for 'concentrate of proteolytic enzymes enriched in bromelain' gel. The FDA has determined that the application cannot be approved in its present form due to various deficiencies related to product quality, clinical study data integrity, and safety information.
IssuedJan 1, 2023
US FDA• NexoBrid (concentrate of proteolytic enzymes enriched in bromelain gel)
ALApproval Letter
Approval Letter Other 761219 (Jan 1, 2023)
This document is an 'Other Action Letter' from the FDA regarding Biosimilar License Application (BLA) 761219. It outlines deficiencies related to prescribing information, carton and container labeling, proprietary name, and safety updates, and also includes specific requirements for device testing. The letter instructs the applicant on necessary actions for resubmission to achieve approval.
IssuedJan 1, 2023
US FDA• Yuflyma
ALApproval Letter
Approval Letter Other 204803 (Jan 1, 2022)
The FDA issued a Complete Response letter for DURECT Corporation's New Drug Application (NDA) 204803 for POSIMIR (bupivacaine extended-release solution), indicating that the application cannot be approved in its current form. The primary reasons for non-approval are insufficient clinical data to demonstrate the safety of POSIMIR, specifically regarding adverse events related to shoulder joints, skin/underlying tissues (bruising, hematoma, pruritus, dehiscence), and neurologically related adverse events (dizziness, dysgeusia, headache, hypoesthesia, paresthesia, somnolence). The letter outlines specific additional studies required to characterize the risk profile and details requirements for a comprehensive safety update.
IssuedJan 1, 2022
US FDA• POSIMIR (bupivacaine extended-release solution for instillation) 660 mg/ 5mL (132mg/mL), 13.2%
ALApproval Letter
Approval Letter Other 210526 (Jan 1, 2022)
The FDA issued a Complete Response letter for New Drug Application (NDA) 210526 for Dyanavel XR (amphetamine) extended-release tablets, indicating that the application cannot be approved in its current form. The letter outlines deficiencies related to manufacturing facility inspections, prescribing information, medication guide requirements, proprietary name resubmission, and the need for a comprehensive safety update.
IssuedJan 1, 2022
US FDA• Dyanavel XR (amphetamine) extended-release tablets 5 mg, 10 mg, 15 mg, and 20 mg
ALApproval Letter
Approval Letter Other 210282 (Jan 1, 2022)
This is a Complete Response letter from the FDA to Hospira, Inc. regarding their New Drug Application (NDA) 210282 for Daptomycin for Injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, product quality (elemental impurities), and prescribing information. The letter outlines specific requirements for addressing these issues, including a comprehensive safety update, and provides instructions for resubmission or other actions.
IssuedJan 1, 2022
US FDA• Daptomycin for Injection, 350 mg/vial, 500 mg/vial
ALApproval Letter
Approval Letter Other 210735 (Jan 1, 2022)
The FDA issued a Complete Response letter for AuroMedics Pharma LLC's New Drug Application (NDA) 210735 for Cyclophosphamide Injection, indicating that the application cannot be approved in its current form due to several deficiencies. These deficiencies include unresolved issues from a facility inspection, non-conformance of proposed Prescribing Information (PI) with regulatory requirements, and incomplete safety update information.
IssuedJan 1, 2022
US FDA• Cyclophosphamide Injection, 500 mg/2.5 mL and 1 g/5 mL
ALApproval Letter
Approval Letter Other 211988 (Jan 1, 2022)
This document is a Complete Response Letter from the FDA to Heron Therapeutics, Inc. regarding their New Drug Application (NDA) 211988 for Zynrelef. The FDA has determined that the application cannot be approved in its present form due to several nonclinical and other deficiencies, and provides recommendations for addressing these issues.
IssuedJan 1, 2022
US FDA• Zynrelef (bupivacaine and meloxicam) Solution 60mg / 1.8mg, 200mg / 6mg, 300mg / 9mg, 400mg / 12mg
ALApproval Letter
Approval Letter Other 211950 (Jan 1, 2022)
This is a Complete Response letter from the FDA to Clearside Biomedical, Inc. regarding their New Drug Application (NDA) 211950 for XIPERE (triamcinolone acetonide ophthalmic suspension). The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to manufacturing, product safety data, process robustness, and compliance with patent certification regulations.
IssuedJan 1, 2022
US FDA• XIPERE (triamcinolone acetonide ophthalmic suspension) for suprachoroidal injection
ALApproval Letter
Approval Letter Other 212304 (Jan 1, 2022)
This letter from the FDA's Center for Drug Evaluation and Research outlines deficiencies found in New Drug Application (NDA) 212304. It provides specific instructions for revisions to labeling, packaging, and submission content, including a comprehensive safety update, to address these deficiencies.
IssuedJan 1, 2022
US FDA• ADLARITY
ALApproval Letter
Approval Letter Other 212854 (Jan 1, 2022)
This document is a Complete Response letter from the FDA to Adamis Pharmaceuticals Corporation regarding their New Drug Application (NDA) for Naloxone HCl Injection, 5 mg/0.5 mL. The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to clinical data, device design, risk analysis, human factors, and statistical validation of manufacturing processes and device performance.
IssuedJan 1, 2022
US FDA• Naloxone HCl Injection, 5 mg/0.5 mL (ZIMHI)
ALApproval Letter
Approval Letter Other 213218 (Jan 1, 2022)
This letter from the FDA's Center for Drug Evaluation and Research addresses an applicant regarding deficiencies in application number 213218Orig1s000. It requests the submission of draft carton and container labeling, resubmission of the proposed proprietary name, and a comprehensive safety update. The safety update must include detailed new safety data from clinical studies, comparisons with original data, retabulation of trial discontinuations, case report forms for adverse events, updated exposure information, a summary of worldwide safety experience, and English translations of foreign labeling. The applicant is required to resubmit or take other actions within one year, fully addressing all deficiencies, or the application may be considered withdrawn. The drug cannot be marketed until approved.
IssuedJan 1, 2022
US FDA• SOAAANZ
ALApproval Letter
Approval Letter Other 213426 (Jan 1, 2022)
This is a Complete Response Letter from the FDA to Esteve Pharmaceuticals, S.A. regarding their New Drug Application (NDA) 213426 for celecoxib and tramadol hydrochloride tablets. 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, Risk Evaluation and Mitigation Strategy (REMS) requirements, and safety updates.
IssuedJan 1, 2022
US FDA• celecoxib and tramadol hydrochloride tablets

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Approval Letter Other 761192 (Jan 1, 2023)

Approval Letter Other 761219 (Jan 1, 2023)

Approval Letter Other 204803 (Jan 1, 2022)

Approval Letter Other 210526 (Jan 1, 2022)

Approval Letter Other 210282 (Jan 1, 2022)

Approval Letter Other 210735 (Jan 1, 2022)

Approval Letter Other 211988 (Jan 1, 2022)

Approval Letter Other 211950 (Jan 1, 2022)

Approval Letter Other 212304 (Jan 1, 2022)

Approval Letter Other 212854 (Jan 1, 2022)

Approval Letter Other 213218 (Jan 1, 2022)

Approval Letter Other 213426 (Jan 1, 2022)