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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 217-228 of 291 letters

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 761180 (Jan 1, 2022)

This letter from the FDA's Center for Drug Evaluation and Research addresses deficiencies in Biologics License Application (BLA) 761180, specifically requesting a resubmission of the proposed proprietary name and a comprehensive safety update.

IssuedJan 1, 2022
US FDA• Unknown
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
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 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
ALApproval Letter

Approval Letter Other 209388 (Jan 1, 2021)

This is a Complete Response letter from the FDA to Evoke Pharma, Inc. regarding their New Drug Application (NDA) for Gimoti (metoclopramide nasal spray). The FDA has determined that the application cannot be approved in its present form due to deficiencies in clinical pharmacology and product/device quality.

IssuedJan 1, 2021
US FDA• Gimoti (metoclopramide nasal spray)
ALApproval Letter

Approval Letter Other 208419 (Jan 1, 2021)

This document is a Complete Response letter from the FDA to Actavis LLC regarding their New Drug Application (NDA) for Pemetrexed Injection 25 mg/mL. The FDA has determined that the application cannot be approved in its current form and outlines specific deficiencies and recommendations across Chemistry, Manufacturing, and Controls (CMC), Prescribing Information, and Safety Update sections.

IssuedJan 1, 2021
US FDA• Pemetrexed Injection 25 mg/mL
ALApproval Letter

Approval Letter Other 209511 (Jan 1, 2021)

The FDA issued a Complete Response letter for New Drug Application (NDA) 209511 for bupivacaine hydrochloride collagen-matrix implants, indicating that the application cannot be approved in its current form. The letter details several nonclinical, product quality, and safety deficiencies, along with issues regarding the proposed indication and labeling, and provides recommendations for addressing these issues.

IssuedJan 1, 2021
US FDA• bupivacaine hydrochloride collagen-matrix implants, 100 mg per implant
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

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