FDA Letters Issued in 2024

This FDA letter addresses deficiencies in New Drug Application (NDA) 219357, providing instructions for the applicant to resubmit the application. Key areas of focus include labeling, proprietary name, and a comprehensive safety update, along with general resubmission requirements and timelines.

The FDA has issued a Complete Response Letter for NDA 210934 for sotagliflozin, indicating that the application is not approvable. The agency concluded that the submitted data did not support a favorable benefit-risk assessment for sotagliflozin in patients with Type 1 Diabetes (T1D) and eGFR ≥60 ml/min/1.73m2 and UACR ≥30 mg/g, primarily due to the risk of Diabetic Ketoacidosis (DKA) outweighing the modest glycemic and other non-glycemic benefits. The letter outlines deficiencies and suggests potential paths forward, including conducting new clinical safety trials to demonstrate adequate DKA risk mitigation and providing additional data for T1D patients with eGFR <60 ml/min/1.73m2.

The FDA has identified numerous deficiencies in NDA 218828 for glepaglutide, primarily concerning the interpretability and persuasiveness of efficacy results from clinical trials (EASE-1, EASE-2, EASE-3, EASE-4, ZP1848-15073) and limitations in the safety database. Issues include protocol deviations, incomplete documentation, data reliability concerns, inadequate qualitative and quantitative analyses for clinically meaningful change, lack of confirmatory evidence, and inconsistent dose responses. Furthermore, the safety database is deemed insufficient for a new molecular entity intended for chronic administration, with multiple safety concerns identified and significant reliability issues found during a clinical investigator site inspection. The FDA recommends conducting a new, well-controlled trial to address these deficiencies before resubmission.

This FDA letter outlines deficiencies and requirements for the resubmission of Biologics License Application (BLA) 761433, providing instructions for updated labeling, clinical data, safety information, and product quality assessments.

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 212271. It outlines deficiencies and provides instructions for the applicant to address issues related to prescribing information, carton and container labeling, proprietary name, and safety updates. The letter also specifies requirements for resubmission.

This document is a communication from the U.S. Food and Drug Administration (FDA) regarding New Drug Application (NDA) 214610. It outlines specific requirements related to product quality, prescribing information, and safety data, and provides instructions for resubmission or further actions.

This document is a deficiency letter from the FDA regarding Biologics License Application (BLA) 761271. It outlines several deficiencies and required actions related to facility inspection, labeling, proprietary name, and a comprehensive safety update, which must be addressed for the application to be approved.

This document outlines specific requirements for updating and presenting safety data for NDA 218762, including new clinical trial data, adverse event frequencies, trial discontinuations, and worldwide safety experience. It also sets a deadline for resubmission or other actions.

The FDA has identified significant deficiencies in NDA 219195 for govorestat, concluding that the currently available evidence does not support the drug's effectiveness for treating CG, nor does it validate plasma galactitol as a reasonably likely surrogate endpoint for accelerated approval. The agency requires substantial evidence of effectiveness, including new adequate and well-controlled clinical trials, and comprehensive data to support galactitol's role as a surrogate endpoint.

This letter from the FDA outlines deficiencies in a Biologics License Application (BLA) for a biosimilar product, providing specific instructions for a safety update, proprietary name resubmission, and general resubmission procedures to achieve approval.

This document is a deficiency letter from the FDA regarding Biologics License Application (BLA) 761147. It addresses proposed labeling, proprietary name, and outlines detailed requirements for a safety update, including specific data presentation and analysis. It also provides instructions for resubmission and potential consequences of inaction.

This document outlines specific requirements for updating safety data in a New Drug Application (NDA), focusing on incorporating new clinical trial findings, adverse event reporting, and global safety information.

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 218600. It outlines deficiencies and provides detailed instructions for resubmitting the application, focusing on labeling, proprietary name, and safety updates.

The FDA has reviewed a New Drug Application (NDA 219045) for a naloxone HCl, 4 mg, nasal spray. While the product's efficacy is considered comparable to Narcan, significant safety concerns exist due to its higher systemic exposure, which is greater than Narcan. This higher exposure poses an increased risk of precipitated opioid withdrawal, especially in opioid-dependent individuals and in a nonprescription setting without healthcare guidance. The submitted safety data is deemed inadequate, and communicating this risk effectively on a Drug Facts Label (DFL) is challenging. The FDA recommends either product reformulation to achieve lower systemic exposure or conducting further studies to establish the safety of the current higher-exposure formulation for nonprescription use, along with potential labeling modifications. A comprehensive safety update is also required.

This FDA letter communicates deficiencies in NDA 218923, deferring clinical inspections and reserving comments on labeling and proprietary name until the application is otherwise adequate. It outlines specific requirements for a safety update, including detailed data presentation and analysis, and provides instructions for resubmission within one year, emphasizing that all deficiencies must be addressed.

This letter from the FDA communicates deficiencies found in New Drug Application (NDA) 217724 and outlines requirements for a complete response. Key areas of concern include manufacturing compliance (CGMP), prescribing information (labeling) content and format, proprietary name review, safety updates, and specific clinical data requests related to pediatric dosing, safety, and efficacy, particularly for infants with low body weight or prematurity. The applicant is required to address these deficiencies within one year, with specific instructions for resubmission.

This FDA letter outlines deficiencies for New Drug Application (NDA) 218026 and provides detailed instructions for resubmission, focusing on labeling requirements, safety updates, and administrative procedures.

The FDA issued a complete response letter for NDA 215455, citing substantial concerns regarding the reliability of safety data due to inconsistent adverse event reporting, particularly for 'positive' effects related to abuse potential. The application also failed to demonstrate durable treatment effects for midomafetamine in PTSD, largely due to design issues and potential selection bias in the MAPP1, MAPP2, and MPLONG studies. The FDA recommends a new clinical trial to address durability and safety characterization, including specific design elements to minimize bias and ensure comprehensive AE capture. Additionally, the FDA identified data gaps in laboratory assessments, cardiac safety, and hERG evaluation that need to be addressed in any resubmission, along with recommendations for characterizing psychotherapy's contribution and improving study diversity.

The FDA issued a Complete Response letter for NDA 217338 for naproxen sodium, dextromethorphan hydrobromide, guaifenesin extended-release (ER) tablet, indicating that the application cannot be approved in its current form due to insufficient evidence supporting the proposed 12-hour duration of action and dosing regimen.

This document is a Complete Response Letter (CRL) from the FDA for New Drug Application (NDA) 216195, outlining deficiencies that prevent approval and detailing the requirements for a complete response resubmission, including specific instructions for a safety update and addressing facility issues.

This FDA letter for NDA 217433 outlines deficiencies related to product quality, human factors, prescribing information, carton and container labeling, and safety updates. The primary concern is the user interface's failure to support safe and effective use, as demonstrated by a human factors validation study where participants failed to administer the intended dose. The letter requires the applicant to implement user interface revisions, provide data demonstrating effectiveness, and submit a safety update with detailed new safety data. It also reserves comment on labeling until the application is otherwise adequate and provides instructions for resubmission.

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 215029. It outlines deficiencies in the application, reserves comment on proposed labeling, addresses the proprietary name, and provides detailed instructions for a safety update and the resubmission process. The letter also specifies the timeframe for resubmission and options for meetings.

This document is a deficiency letter from the U.S. Food and Drug Administration (FDA) regarding Biologics License Applications (BLA) 761326/Original 1 and 761326/Original 2. It outlines deficiencies found during facility inspections, clinical data review (specifically for BLA 761326/Original 1 concerning glycemic control in type 1 diabetes), and provides instructions for addressing prescribing information, proprietary name, and safety updates. The letter also specifies actions required within one year for resubmission or other regulatory actions.

This document is a letter from the U.S. Food and Drug Administration (FDA) regarding New Drug Application (NDA) 218345. It addresses product quality, regulatory aspects, prescribing information, carton and container labeling, and provides detailed instructions for a required safety update.

This letter from the FDA addresses deficiencies in Biologics License Application (BLA) 761377, requesting specific updates and submissions related to labeling, proprietary name, and a comprehensive safety update. It outlines the requirements for resubmission and the timeline for action.

This document is a Complete Response Letter (CRL) from the FDA for Biologics License Application (BLA) 761366, detailing deficiencies that must be addressed before the application can be approved. It outlines specific requirements for labeling revisions, proprietary name resubmission, and a comprehensive safety update, along with instructions for resubmission or other actions.

This is a Complete Response Letter from the FDA to Rocket Pharmaceuticals, Inc. regarding their Biologics License Application (BLA) for marnetegragene autotemcel. The FDA has concluded that they cannot grant final approval due to deficiencies, primarily in Chemistry, Manufacturing, and Controls (CMC), and also reserves comment on labeling until the application is otherwise acceptable. The letter outlines requirements for resubmission and options for discussion.

This document outlines the requirements for submitting a safety update as part of a New Drug Application (NDA) response, detailing specific data presentation and analysis expectations for nonclinical and clinical studies.

This document is a Complete Response Letter (CRL) from the FDA for New Drug Application (NDA) 218506, outlining deficiencies that prevent approval in its current form. It addresses issues related to product quality, proprietary name, facility inspections, and requires a comprehensive safety update.

This FDA letter communicates deficiencies in New Drug Application (NDA) 218698, reserving comment on proposed labeling until the application is otherwise adequate. It outlines specific requirements for a safety update, details for resubmission, and options for meeting requests.

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 218317. It outlines deficiencies identified during the review process, particularly concerning facility inspections, safety updates, and labeling, and provides instructions for a complete response and resubmission.

This document is a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) to an applicant regarding Biologics License Application (BLA) 761308. It outlines deficiencies found in the application and specifies additional information and actions required for potential approval, particularly focusing on safety data, clinical trial information, and administrative procedures for resubmission.

This document outlines requirements for New Drug Application (NDA) submissions, specifically regarding the resubmission of a proprietary name and the provision of a comprehensive safety update when responding to application deficiencies. The safety update must include detailed data from all nonclinical and clinical studies, incorporating new findings, retabulated adverse event frequencies, and narrative summaries for serious events or deaths.

This document is a letter from the FDA regarding New Drug Application (NDA) 216987, outlining deficiencies that need to be addressed before approval. It specifies requirements for labeling revisions, a comprehensive safety update, and procedures for resubmission or other actions.

This FDA letter, pertaining to Biologics License Application (BLA) 761187, outlines deficiencies and requirements for the applicant to address. It covers aspects of prescription drug labeling, carton and container labeling, proprietary name resubmission, and a comprehensive safety update. The letter also provides instructions for resubmission and notes that the product cannot be marketed until approved.

This document is a Complete Response Letter (CRL) from the FDA regarding Biologics License Application (BLA) 761376. It outlines deficiencies that prevent approval and provides instructions for resubmission, including requirements for a safety update, proprietary name resubmission, and labeling considerations. Several sections detailing product quality, microbiology, drug substance, and drug product deficiencies are redacted.

This section serves as an attestation for an electronic record, confirming it was signed electronically and providing details of the electronic signature, including the date, time, and a reference ID.

This document is a deficiency letter from the FDA regarding Biologics License Application (BLA) 761356, outlining specific requirements and recommendations for its resubmission. It addresses deficiencies related to facility inspections, prescribing information, proprietary name, and a comprehensive safety update.

This section provides feedback from the FDA regarding a Biologics License Application (BLA 761147), specifically addressing proposed labeling, proprietary name, and the requirement for a safety update. It encourages the applicant to review relevant FDA resources and guidance documents.

This FDA letter communicates deficiencies in New Drug Application (NDA) 218524, primarily concerning prescribing information (PI) and safety updates. It outlines specific requirements for revising labeling, submitting safety data, and the process for resubmission or other actions within one year.

This FDA letter addresses deficiencies in New Drug Application (NDA) 218408, specifically regarding prescribing information, carton and container labeling, and safety updates. It outlines requirements for resubmission and emphasizes that the product cannot be marketed until approved.

This letter from the FDA addresses deficiencies in a Biologics License Application (BLA 761357) and outlines requirements for its resubmission. It covers facility inspections, prescribing information, proprietary name, and a detailed safety update, emphasizing that the product cannot be marketed until approved.

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding deficiencies found in their Biologics License Application (BLA) 761303/Original 2. It outlines specific requirements for addressing issues related to clinical trial completion, prescribing information, proprietary name, and safety updates, which must be fulfilled for a successful resubmission. The letter also provides guidance on the resubmission process and timelines.

This letter from the FDA identifies deficiencies in a Biologics License Application (BLA) for a product intended for follicular lymphoma, specifically regarding the timely completion of confirmatory trials. It outlines requirements for resubmission, including addressing trial progress, updating prescribing information and safety data, and resubmitting the proprietary name. The letter also provides instructions for the format and content of the resubmission and sets a one-year deadline for action.

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 210168. It outlines the required actions for the applicant to take within one year, primarily focusing on resubmission or other actions under 21 CFR 314.110, and details the proper format and content for a resubmission. It also mentions the option to request a meeting with the FDA.

This document from the U.S. Food and Drug Administration (FDA) outlines significant deficiencies in New Drug Application (NDA) 218223 for GA Depot as a treatment for relapsing forms of multiple sclerosis (RMS). The FDA found the Phase 3 trial (Study Mapi GA Depot Phase III – 001) did not provide interpretable or persuasive efficacy findings, failed to establish an adequate scientific bridge to Copaxone, and exhibited numerous issues with trial design, data quality, and reliability. Furthermore, the submitted safety data were deemed inadequate, and the study raised new safety concerns, including severe injection site reactions and systemic injection-related reactions, suggesting important differences from Copaxone.

This letter from the FDA outlines deficiencies in NDA 215749, primarily focusing on the requirement for a comprehensive safety update and instructions for resubmission. It details specific data and documentation needed for the safety update, including new and combined safety data, adverse event comparisons, and worldwide safety experience. The letter also sets a one-year deadline for resubmission or other actions and provides guidance on the format and content of a resubmission.

The FDA has identified several deficiencies in the New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia. Key issues include insufficient evidence for efficacy from Study C07, lack of data on co-administration with antipsychotics, unproven clinical meaningfulness of the observed effect on negative symptoms, and inadequate long-term safety data. Additionally, the proposed strategy for mitigating QTc prolongation risk based on CYP2D6 genotyping is deemed insufficient, requiring a robust companion diagnostic device. The FDA requires the submission of additional studies and data to address these deficiencies before the application can be approved.

This document is an FDA letter regarding New Drug Application (NDA) 217556 for cefepime for injection and taniborbactam for injection. It outlines specific deficiencies and requirements that must be addressed for the application to be approved, including detailed instructions for presenting safety data, clinical pharmacology analyses, and resubmission procedures.

This FDA letter acknowledges receipt of a draft labeling for NDA 218470 and reserves further comment until the application is otherwise adequate. It provides detailed instructions for a required safety update, outlines specific data presentation requirements for adverse events and clinical trial information, and sets a one-year deadline for resubmission or other actions under 21 CFR 314.110. The letter also specifies formatting for resubmissions and states that the product cannot be marketed until approved.

This document is a deficiency letter from the U.S. Food and Drug Administration (FDA) regarding New Drug Application (NDA) 214315. It outlines several deficiencies related to human factors, prescribing information, carton and container labeling, proprietary name, and safety updates. The FDA found that the proposed product's user interface does not support safe and effective use due to identified use errors and close calls during human factors validation studies. The letter requests specific actions and data from the applicant to resolve these deficiencies before the application can be approved.

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 218528. It outlines specific requirements and recommendations concerning prescribing information, carton and container labeling, medication guides, proprietary name resubmission, and a comprehensive safety update. The letter also includes additional Chemistry, Manufacturing, and Controls (CMC) comments.

This is a Complete Response Letter from the FDA to Hikma Pharmaceuticals USA, Inc. for New Drug Application (NDA) 218258 for phenobarbital sodium injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies in clinical data, abuse potential assessment, facility inspections, and other areas, and provides recommendations for addressing these issues.

This FDA letter for NDA 215291 outlines deficiencies that must be resolved before the application can be approved. It provides detailed requirements for labeling revisions, proprietary name resubmission, and a comprehensive safety update, including specific data presentation formats for clinical trial safety information. It also sets a one-year deadline for resubmission or other actions and advises on meeting requests.

This FDA letter, identified as NDA 217294, outlines requirements for a safety update and procedures for resubmission following deficiencies. It mandates specific data presentation for safety information, including adverse events, discontinuations, and worldwide experience, and sets a one-year deadline for resubmission or other actions under 21 CFR 314.110.

This is a Complete Response Letter from the FDA to Delcath Systems, Incorporated, for their New Drug Application (NDA) 201848 for Melblez Kit. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to clinical effectiveness, clinical pharmacology, and product quality. Key issues include a lack of substantial evidence of effectiveness where benefits outweigh risks, insufficient pharmacokinetic characterization for the proposed commercial product, and an inadequate toxicological risk assessment of leachables and extractables from the device components of the commercial configuration.

The FDA issued two Complete Response Letters for NDA 204311 for Abacavir and Lamivudine Tablets for Oral Suspension, indicating that the application cannot be approved in its current form. The primary reasons for non-approval include unresolved deficiencies from facility inspections at Mylan Laboratories Limited Unit-8 and requirements for revisions to prescribing information, carton/container labeling, and the medication guide. The letters provide detailed instructions for addressing these issues and for resubmitting the application.

This document is a Complete Response letter from the FDA to AFT Pharmaceuticals, Ltd. regarding New Drug Application (NDA) 209471 for COMBOGESIC. The FDA has determined that the application cannot be approved in its present form due to various deficiencies across clinical, statistical, nonclinical, product quality, and facility inspection areas. The letter outlines specific requirements for revising labeling, providing safety updates, addressing data quality issues, justifying drug substance specifications, analyzing elemental impurities, and confirming process validation. It also details the process and timeline for resubmission or other actions.

This is a Complete Response letter from the FDA to Braeburn Inc. for their New Drug Application (NDA) 210136 for BRIXADI (buprenorphine) extended-release injection. 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, safety update requirements, and mandated postmarketing studies.

The FDA issued a Complete Response letter for New Drug Application (NDA) 210852 for Cyclophosphamide Injection, indicating that the application cannot be approved in its current form due to deficiencies related to facility inspections and requiring a comprehensive safety update.

The FDA issued a Complete Response letter for NDA 211413 for Cefazolin for Injection USP, indicating non-approval due to deficiencies primarily related to the inadequate safety qualification of identified leachables and incomplete safety updates. The letter provides specific recommendations for addressing these issues and outlines the process for resubmission or further action.

This document contains two FDA letters concerning NDA 211566 for Sitagliptin Tablets. The first letter, dated March 3, 2023, details extensive requirements for updating safety data in a resubmission, including incorporating new clinical trial data, comparing adverse event frequencies, providing worldwide safety experience, and translating foreign labeling. It mandates resubmission or other actions within one year. The second letter, dated September 2, 2021, grants tentative approval for Sitagliptin Tablets for type 2 diabetes, contingent on the resolution of patent protection and exclusivity issues, specifically a patent infringement suit related to a Paragraph IV certification. It outlines the conditions for lifting the 30-month stay and the process for requesting final approval, which includes a safety update and confirmation of any changes to the application's conditions.

The FDA issued a Complete Response letter for NDA 212849 for Rykindo (risperidone) for extended-release injectable suspension, indicating that the application cannot be approved in its present form. The FDA identified deficiencies primarily related to clinical and clinical pharmacology concerns regarding unexplained concentration spikes and potential dose dumping, disagreeing with the applicant's root-cause analysis. Additional deficiencies include biopharmaceutics issues, pending labeling comments, and the need for a comprehensive safety update.

This document is a Complete Response Letter (CRL) from the FDA to Verrica Pharmaceuticals Inc. for New Drug Application (NDA) 212905, indicating that the application for cantharidin topical solution, 7% cannot be approved in its present form. It outlines specific deficiencies and provides detailed instructions for resubmission, focusing on updated labeling, proprietary name resubmission, and a comprehensive safety update.

This is a Complete Response Letter from the FDA to Teva Neuroscience, Inc. regarding New Drug Application (NDA) 213586 for risperidone extended-release injectable suspension. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to clinical data quality, syringe and carton labeling, and proprietary name submission. The letter outlines specific reasons for non-approval and provides recommendations for addressing these issues, including requirements for a safety update and options for resubmission or further action.

This is a Complete Response Letter from the FDA to Ardelyx, Inc. regarding their New Drug Application (NDA) for tenapanor hydrochloride tablets. The FDA has determined that the application cannot be approved in its present form due to insufficient evidence of a clinically relevant treatment effect on serum phosphorus, despite acknowledging the drug's efficacy in reducing serum phosphorus. The letter outlines specific deficiencies and requirements for resubmission.

The FDA issued a Complete Response letter for NDA 213972 for sulopenem etzadroxil and probenecid tablets, indicating that the application cannot be approved in its current form due to a lack of substantial evidence of effectiveness from clinical trials and other deficiencies related to labeling, barcodes, safety updates, and nonclinical PK/PD studies.

This is a Complete Response letter from the FDA to Takeda Pharmaceuticals U.S.A., Inc. for their New Drug Application (NDA) 213976 for Eohilia (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE). The FDA determined that the application cannot be approved in its current form due to insufficient evidence of effectiveness, citing deficiencies in clinical and statistical data, and provides recommendations for resolution.

The FDA issued a Complete Response letter for NDA 214927 for arimoclomol capsules, indicating that the application cannot be approved in its present form due to a lack of substantial evidence of effectiveness. Key concerns include issues with the 5-domain NPC Clinical Severity Scale (5DNPCCSS) as a primary endpoint, the statistical analysis (hypothetical estimand vs. while-on-treatment estimand), and weak/contradictory confirmatory evidence from in vitro and animal studies.

This document is a Complete Response letter from the FDA to CMP Development LLC regarding their New Drug Application (NDA) for sildenafil oral suspension, 10 mg/ml. 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, and safety updates.

This is a Complete Response Letter from the FDA to Galephar Pharmaceutical Research Inc. regarding their New Drug Application (NDA) 215040 for Legubeti (acetylcysteine) for oral solution. The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to clinical data, regulatory compliance, and safety information.

The FDA issued a Complete Response letter for NDA 215064 for Filsuvez (birch triterpenes) gel, indicating that the application cannot be approved in its current form due to insufficient evidence of effectiveness for the proposed indication of treating wounds associated with inherited epidermolysis bullosa (EB). The letter details specific deficiencies in clinical data and outlines requirements for a safety update and other submissions.

The FDA issued a Complete Response letter for Shilpa Medicare Limited's New Drug Application (NDA 215179) for Pemetrexed Injection, indicating that the application cannot be approved in its current form due to unresolved product quality issues, facility inspection deficiencies, and outstanding safety update requirements. The letter outlines specific actions and data submissions required for potential approval.

This document is an 'Other Action Letter' from the FDA to an applicant regarding New Drug Application (NDA) 215151. It outlines deficiencies and required actions for the applicant to address within one year to move the application towards approval. Key areas of focus include labeling updates, proprietary name resubmission, and a comprehensive safety update.

The FDA issued a Complete Response Letter for Akebia Therapeutics, Inc.'s New Drug Application (NDA) 215192 for vadadustat tablets. The application was not approved in its current form due to an unfavorable benefit-risk assessment, citing major safety concerns including major adverse cardiac events (MACE), thromboembolic events, and drug-induced liver injury (DILI), which were deemed to outweigh the benefits for the proposed indication of anemia associated with chronic kidney disease (CKD) in adults not on dialysis and on dialysis.

The FDA issued a Complete Response Letter for NDA 215212 for Meropenem for Injection 2 g/vial, indicating that the application cannot be approved in its current form due to deficiencies in nonclinical, product quality, and safety update sections. The letter outlines specific issues and provides recommendations for resolution, requiring the applicant to address all deficiencies within one year for resubmission.

This is a Complete Response Letter from the FDA to AFT Pharmaceuticals Ltd. regarding their New Drug Application (NDA) 215320 for Combogesic (acetaminophen/ibuprofen) solution for injection. The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to nonclinical data (toxicological risk assessment for leachables), prescribing information, carton and container labeling, medication guide, proprietary name, and the need for a safety update.

This is a Complete Response letter from the FDA to Braintree Laboratories, Inc. regarding New Drug Application (NDA) 215344 for Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride) for oral solution. The FDA has determined that the application cannot be approved in its present form due to product quality/facility inspection deficiencies, issues with prescribing information, carton and container labeling, and the need for a comprehensive safety update.

This is a Complete Response letter from the FDA to Almatica Pharma, LLC, for their New Drug Application (NDA) 215721 for zolpidem tartrate capsules. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to product quality, prescribing information, medication guide, and safety updates. The letter outlines specific requirements and recommendations for the applicant to address these issues.

This is a Complete Response letter from the FDA to Liqmeds Worldwide Limited regarding New Drug Application (NDA) 216482 for mycophenolate mofetil oral suspension. The application cannot be approved in its present form primarily due to the lack of a required Risk Evaluation and Mitigation Strategy (REMS). The letter outlines specific deficiencies and provides recommendations for addressing them, including detailed requirements for a safety update and submission procedures.

This is a Complete Response letter from the FDA to Ascendis Pharma Bone Diseases A/S regarding their New Drug Application (NDA) 216490 for palopegteriparatide injection. The FDA has determined that the application cannot be approved in its present form due to unresolved deficiencies related to product quality/device, labeling, and requires specific safety updates and postmarketing studies.

The FDA issued a Complete Response letter for NDA 217202 for landiolol injection, indicating that the application cannot be approved in its current form due to deficiencies related to product quality, manufacturing, prescribing information, proprietary name, and safety updates. The letter also outlines a postmarketing requirement to assess drug transporter inhibition.

This is a Complete Response letter from the FDA to Botanix SB Inc. regarding their New Drug Application (NDA) 217347 for sofpironium bromide. The FDA has determined that the application cannot be approved in its present form due to deficiencies primarily related to human factors study results and the need for a safety update.

The FDA issued a Complete Response letter for Takeda Pharmaceuticals' Biologics License Application (BLA) 761133 for MLN0002 SC, indicating that the application cannot be approved in its current form due to various deficiencies. The letter details specific recommendations across product quality, human factors, labeling (device, carton, container, prescribing information, medication guide), proprietary name, and facility inspections.

This document is a Complete Response Letter from the FDA to Bio-Thera Solutions Ltd. regarding their Biologics License Application (BLA) 761198 for BAT1706. The FDA has determined that the application cannot be approved in its present form due to various deficiencies across clinical pharmacology, product quality, labeling, and safety updates. The letter outlines specific issues and provides recommendations for addressing them.

This is a Complete Response Letter from the FDA to Hugel, Inc. regarding their Biologics License Application (BLA) for letibotulinumtoxinA injection. The FDA has determined that the application cannot be approved in its present form due to several deficiencies, including unresolved facility inspection issues, pending labeling comments, and requirements for a comprehensive safety update.

This letter from the FDA's Center for Drug Evaluation and Research outlines deficiencies in Biologics License Application (BLA) 761248 for Kisunla and provides detailed requirements for a resubmission. Key areas addressed include long-term safety characterization, prescribing information, carton and container labeling, proprietary name, a comprehensive safety update, and product quality specifications. The applicant is required to address all deficiencies within one year to avoid withdrawal of the application.

This is a Complete Response Letter from the FDA to Fresenius Kabi USA, LLC, for their Biologics License Application (BLA) 761275 for MSB11456. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facilities, and requires a comprehensive safety update and other technical revisions before approval.

The FDA issued a Complete Response letter for Biologics License Application (BLA) 761299 for AVT02, indicating that the application cannot be approved in its current form due to deficiencies. The letter outlines specific requirements for resubmission, including resolving facility inspection issues, updating labeling, resubmitting the proprietary name, and providing a comprehensive safety update.

This is a Complete Response Letter from the FDA to Eli Lilly and Company regarding their Biologics License Application (BLA) for lebrikizumab injection. The FDA has determined that the application cannot be approved in its present form due to unresolved product quality issues related to manufacturing facility deficiencies, data reliability concerns, and pending labeling and proprietary name reviews. The letter outlines specific deficiencies and provides recommendations for resolution, including a comprehensive safety update.

The FDA issued a Complete Response letter for Biologics License Application (BLA) 761343 for AVT04, indicating that the application cannot be approved in its present form due to outstanding deficiencies related to facility inspections, labeling, safety updates, product quality, and microbial quality.

This letter from the FDA's Center for Drug Evaluation and Research addresses deficiencies in Biologics License Application (BLA) 761365 for IMAB362 drug product. It outlines specific requirements related to analytical methods, manufacturing, labeling, proprietary name, and a comprehensive safety update, instructing the applicant on necessary actions for potential approval.

This is a Complete Response Letter from the FDA to Regeneron Pharmaceuticals, Inc. regarding their Biologics License Application (BLA) 761355 for Eylea HD (aflibercept) Injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies in manufacturing facilities and controls, specifically non-compliance with current good manufacturing practice (cGMP) regulations.