FDA Letters Issued in 2025

The FDA issued a 'not approvable' letter for New Drug Application (NDA) 21-164 for Gepirone Hydrochloride Extended Release tablets, citing a lack of substantial evidence for its effectiveness in treating major depressive disorder (MDD) and several Chemistry, Manufacturing, and Controls (CMC) deficiencies. The agency found that only 2 out of 12 studies showed a significant effect, with active comparators often outperforming gepirone ER, and a meta-analysis of the failed studies showed no significant effect. Additionally, the longer-term maintenance efficacy trial yielded negative results, and the applicant's post-hoc attempt to repair it was deemed invalid. The FDA also noted deficiencies in impurity acceptance criteria and stability data.

The FDA issued a 'not approvable' letter for Kyowa Pharmaceutical, Inc.'s New Drug Application (NDA 22-075) for istradefylline tablets (20mg, 40mg) due to inadequate information. The deficiencies cited include insufficient clinical evidence of meaningful benefit beyond a modest effect on 'OFF time' in Parkinson's Disease, required Phase 4 clinical pharmacology commitments, and incomplete nonclinical data regarding brain mineralization.

This document is a Complete Response Letter from the FDA to Mallinckrodt Hospital Products IP Limited regarding New Drug Application (NDA) 022231 for Terlivaz (terlipressin) 1 mg injection. The FDA has determined that the application cannot be approved in its current form due to concerns about the risk-benefit profile, particularly regarding the incidence of serious adverse events like respiratory failure, and unresolved questions about the clinical significance of the primary endpoint. The letter outlines specific deficiencies and required actions for resubmission.

This is a Complete Response letter from the FDA to Cyclomedica Australia Pty Ltd. regarding their New Drug Application (NDA) for Technegas™ Technetium Tc-99m carbon aerosol. The FDA has determined that the application cannot be approved in its present form due to various deficiencies across product quality (drug substance, drug product, process, device) and clinical aspects, and provides recommendations for addressing these issues.

This is a Complete Response letter from the FDA to Cadence Pharmaceuticals regarding their New Drug Application (NDA) for Ofirmev (acetaminophen) Injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, labeling, and the need for a comprehensive safety update.

The FDA issued a Complete Response letter for Ferring Pharmaceuticals Inc.'s New Drug Application (NDA 022517) for Nocdurna (desmopressin) Orally Disintegrating Tablets. The application cannot be approved in its current form due to insufficient evidence that the drug's effect on nocturnal voids is clinically meaningful and outweighs the risks of hyponatremia. The FDA recommends conducting a new clinical trial to demonstrate meaningful clinical benefit using patient-reported outcomes and to prospectively evaluate hyponatremia monitoring strategies. The letter also outlines requirements for updating prescribing information, resubmitting the proprietary name, and providing a comprehensive safety update, including data from all nonclinical and clinical studies.

The FDA issued a Complete Response letter for NDA 022561 for cladribine tablets, indicating that the application cannot be approved in its current form. While cladribine was found effective for relapsing remitting multiple sclerosis (RRMS), significant safety concerns, particularly an increased risk of malignancy and lymphopenia, outweigh its benefits. The letter details specific deficiencies in clinical safety data, product quality, and labeling, requiring the applicant to provide additional analyses, studies, and information before resubmission.

This is a Complete Response letter from the FDA to Amgen, Inc. regarding Biologics License Application (BLA) 125522/Original 2 for Repatha (evolocumab). The FDA has determined that the application cannot be approved in its present form due to insufficient clinical data for the proposed 420 mg every two weeks dosing regimen for homozygous familial hypercholesterolemia (HoFH). The letter outlines specific deficiencies and provides recommendations for resubmission, including requirements for additional clinical data, a comprehensive safety update, and labeling revisions.

The document comprises multiple "Complete Response" letters from the FDA to Sun Pharma regarding New Drug Application (NDA) 204417 for Elepsia XR (levetiracetam) extended-release tablets. The letters consistently state that the application cannot be approved in its current form due to unresolved manufacturing facility deficiencies, issues with prescribing information (dosing, format, and content), and, in an earlier letter, concerns regarding bioequivalence data in the fed state and the similarity of plasma concentration-time curves compared to the reference listed drug.

This document is a Complete Response Letter from the FDA to ELC Group regarding New Drug Application (NDA) 205054 for Lutrate®Depot (leuprolide acetate for injection). The FDA has determined that the application cannot be approved in its present form due to deficiencies in clinical/statistical data, product quality, regulatory compliance, prescribing information, proprietary name, facility inspections, and safety update requirements.

This is a Complete Response letter from the FDA regarding CooperSurgical, Inc.'s supplemental New Drug Application (sNDA) for Paragard (intrauterine copper contraceptive), specifically for a new inserter. The application cannot be approved in its current form due to an incomplete facility inspection and numerous deficiencies identified in prescribing information, carton and container labeling, and the placement guide. The letter outlines detailed recommendations and requirements for resubmission, including a comprehensive safety update.

The FDA issued two Complete Response letters for New Drug Application (NDA) 208574 for Romidepsin Injection, indicating that the application cannot be approved in its present form. The letters cite deficiencies related to manufacturing facilities (Teva Parenteral Medicines, Inc. and Teva Pharmaceutical Works Private Limited Company), product quality, and require comprehensive safety updates and revisions to prescribing information.

This is a Complete Response Letter from the FDA to AcelRx Pharmaceuticals, Inc. regarding their New Drug Application (NDA) 209128 for DSUVIA (sufentanil sublingual tablet). The FDA has determined that the application cannot be approved in its present form due to deficiencies related to safety, human factors, prescribing information, proprietary name, Risk Evaluation and Mitigation Strategy (REMS), safety update requirements, and container/carton labeling.

This is a Complete Response letter from the FDA regarding New Drug Application (NDA) 211150/Original 2 for Wakix (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. The FDA has determined that the application cannot be approved in its present form due to a lack of substantial evidence of effectiveness, citing inadequacies in the submitted clinical trials (HARMONY I and HARMONY CTP). The letter outlines the specific deficiencies and provides a path forward, including the requirement for an additional randomized, double-blind, placebo-controlled study.

This letter from the FDA identifies deficiencies in NDA 212097/S-012, specifically regarding dose accuracy testing, chemistry, manufacturing, and controls (CMC) for IV administration, prescribing information, proprietary name resubmission, and a comprehensive safety update. The applicant is required to address these deficiencies within one year to avoid withdrawal of the application.

This is a Complete Response Letter from the FDA to Therakind Limited regarding New Drug Application (NDA) 212479 for Jylamvo (methotrexate) oral solution. The FDA has determined that the application cannot be approved in its present form due to product quality issues related to a manufacturing facility and deficiencies in labeling and safety update submissions.

This FDA letter communicates deficiencies and requirements for the approval of New Drug Application (NDA) 212782. It addresses issues related to prescribing information, carton and container labeling, manufacturing facility inspections, product quality, and safety updates, requiring the applicant to submit a comprehensive response within one year.

The FDA issued Complete Response letters for New Drug Applications (NDAs) 212887 (VOCABRIA) and 212888 (CABENUVA) from ViiV Healthcare Company, indicating that neither application can be approved in its current form due to various deficiencies. Approval of VOCABRIA is contingent on CABENUVA's approval.

This is a Complete Response letter from the FDA to AVEO Pharmaceuticals, Inc. regarding their New Drug Application (NDA 204408) for tivozanib hydrochloride capsules. The FDA has determined that the application cannot be approved in its current form due to deficiencies in clinical data (inconsistent progression-free survival and overall survival results, uninterpretable trial results), product quality (unsupported dissolution acceptance criterion), and pending labeling review. The letter outlines specific recommendations and requirements for addressing these issues for a potential resubmission.

This is a Complete Response Letter from the FDA to Alkermes, Inc. regarding New Drug Application (NDA) 213378 for Lybalvi (olanzapine and samidorphan). The FDA has determined that the application cannot be approved in its present form due to objectionable conditions at a manufacturing facility, pending review of prescribing information, and outstanding clinical data requirements.

This document is a Complete Response letter from the FDA to Genentech, Incorporated, regarding their New Drug Applications (NDAs) and supplemental NDAs (sNDAs) for XOFLUZA (baloxavir marboxil) for the treatment and post-exposure prophylaxis of influenza in pediatric patients. The FDA determined that the applications cannot be approved in their present form due to concerns primarily related to the high frequency of treatment-emergent resistance in pediatric patients and the potential risk of transmission of resistant virus.

This document is a Complete Response letter from the FDA to Gilead Sciences, Inc. regarding their New Drug Applications (NDAs) for lenacapavir injection (NDA 215973) and lenacapavir tablet (NDA 215974). The FDA has determined that the applications cannot be approved in their current form due to various deficiencies related to product quality, prescribing information, proprietary name, and safety updates. The letter outlines specific issues and provides recommendations for addressing them.

This document is a deficiency letter from the FDA regarding New Drug Application (NDA) 216190, outlining specific deficiencies related to prescribing information, carton and container labeling, proprietary name, and a comprehensive safety update. It also details the process for resubmission or other actions, including potential withdrawal if no action is taken within one year.

The FDA issued a Complete Response letter for NDA 217186 for Crexont (carbidopa and levodopa) Extended Release Capsules, indicating that the application cannot be approved in its current form due to insufficient scientific bridging for carbidopa pharmacokinetic exposure and inadequate long-term safety data.

This is a Complete Response letter from the FDA to Astellas Pharma US, Inc. regarding their supplemental New Drug Application (sNDA) for IZERVAY (avacincaptad pegol intravitreal solution). The FDA has determined that the application cannot be approved in its present form due to insufficient data supporting an expanded dosing regimen and outlines deficiencies and recommendations for resubmission.

The FDA issued a Complete Response letter for Azurity Pharmaceuticals, Inc.'s New Drug Application (NDA) 219122 for sitagliptin oral solution, indicating that the application cannot be approved in its current form due to outstanding deficiencies related to facility inspections, prescribing information, proprietary name, and safety updates.

This is a Complete Response letter from the FDA to Eli Lilly and Company regarding their Biologics License Application (BLA) 761215/Original 2 for Rezvoglar (insulin glargine-aglr) injection, seeking interchangeability with U.S.-licensed Lantus. The FDA has determined that the application cannot be approved in its present form, primarily due to the unexpired exclusivity period for a prior interchangeable biological product. The letter outlines regulatory reasons for non-approval, reserves comment on labeling, and details requirements for a safety update if the application is resubmitted.

This is a Complete Response Letter from the FDA to Citius Pharmaceuticals, Inc. regarding their Biologics License Application (BLA) for Lymphir (denileukin diftitox-cxdl) for injection. The FDA has determined that the application cannot be approved in its present form and outlines specific deficiencies and recommendations that must be addressed.

The FDA has issued a provisional determination for BLA 761338/Original 2 for Steqeyma (ustekinumab-stba) injection, finding it meets the interchangeability criteria with Stelara (ustekinumab). However, approval cannot be granted at this time due to unexpired exclusivity for the first interchangeable biosimilar biological products. The letter outlines deficiencies related to labeling, safety updates, and product quality (stability and compatibility studies), and provides instructions for resubmission to obtain eventual approval.

This letter from the FDA outlines deficiencies in a Biologics License Application (BLA 761367) and provides specific requirements for resubmission. It covers various aspects including filling capability data, prescribing information, proprietary name, safety updates, microbiology, product quality, and device performance, emphasizing the need for comprehensive data and adherence to regulatory standards for approval.

This is a Complete Response letter from the FDA to Eli Lilly and Company regarding their Biologics License Application (BLA) 761215/Original 2 for Rezvoglar (insulin glargine-aglr) injection, seeking interchangeability with U.S.-licensed Lantus. The FDA cannot approve the application in its current form primarily because the regulatory exclusivity period for the reference product has not yet expired, as stipulated by section 351(k)(6) of the Public Health Service Act. The letter also outlines specific requirements for a comprehensive safety update, potential labeling revisions, and the necessary next steps for resubmission or other actions.

This document comprises two FDA Complete Response Letters (CRLs) issued to Laboratorios Farmacéuticos ROVI, S.A. for their New Drug Application (NDA) 214835 for Risvan (risperidone ISM) intramuscular injectable suspension. The letters state that the application cannot be approved in its current form due to various deficiencies related to facility inspections, product quality, human factors, and prescribing information.

The FDA has issued a provisional determination that Pyzchiva (ustekinumab-ttwe) is interchangeable with Stelara (ustekinumab) for various formulations, but cannot approve the applications (BLA 761373/Original 2 and BLA 761425/Original 2) due to an unexpired period of exclusivity for the first interchangeable biosimilar biological products. The letter outlines the steps required for future approval once the exclusivity period expires, including submitting an amendment with updated information and fulfilling postmarketing commitments.

The FDA has issued a Complete Response Letter (CRL) for NDA 220049 for vatiquinone, indicating that the application is not ready for approval in its current form. The agency found that the nominally significant findings on exploratory endpoints (Upright Stability Subscale and Modified Fatigue Impact Scale) were not statistically robust or persuasive enough to establish effectiveness, especially given negative results on primary and key secondary endpoints. Concerns were raised regarding statistical observations, handling of missing data, baseline imbalances, and the interpretability of certain outcome assessments. Real-world evidence and biomarker data submitted as confirmatory evidence were deemed insufficient to serve as such without a positive, adequate, and well-controlled study. The FDA requires a new positive, adequate, and well-controlled study to establish effectiveness, suggests a specific study design, and outlines deficiencies related to nonclinical/product quality, labeling, proprietary name, and a comprehensive safety update for any resubmission.

The FDA issued a Complete Response Letter (CRL) for Biologics License Application (BLA) 761211 for AEB1102, indicating that the effectiveness of the drug has not been established for traditional approval. While the drug showed a statistically significant reduction in plasma arginine levels, it failed to meet key secondary clinical endpoints. The FDA suggests that plasma arginine may be a reasonably likely surrogate endpoint for accelerated approval, provided a confirmatory trial is conducted. The letter outlines numerous deficiencies related to clinical efficacy, safety data updates, labeling, proprietary name resubmission, and specific clinical and clinical pharmacology data requirements, including trials for pediatric patients and subcutaneous administration.

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding Biologics License Application (BLA) 761147. It outlines deficiencies in the application, provides guidance on labeling resources, addresses the proprietary name, and details extensive requirements for a safety update that must be included in the resubmission.

This FDA communication outlines specific requirements for the resubmission of Biologics License Application (BLA) 761303, focusing on updated prescribing information, safety data, and general submission procedures. It emphasizes adherence to labeling regulations and guidance, and mandates the provision of comprehensive safety information from clinical trials and worldwide experience.

This FDA letter outlines deficiencies and requirements for Biologics License Application (BLA) 761385 for the drug TVB-009. It details specific instructions for updating labeling (content, carton, and container), resubmitting the proprietary name, and providing a comprehensive safety update. The letter also acknowledges the proposed Risk Evaluation and Mitigation Strategy (REMS) and sets a one-year deadline for resubmission or other actions.

This FDA letter addresses deficiencies in NDA 218923, reserving comment on proposed labeling and proprietary name until the application is otherwise adequate. It mandates a comprehensive safety update, including detailed data presentation, and outlines specific requirements for resubmission within one year, emphasizing that a partial response will not be processed.

This document is a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) to an applicant for New Drug Application (NDA) 205508. The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to facility inspections, manufacturing process controls (CMC data), and bioequivalence/bioavailability data reliability. The letter outlines specific reasons for non-approval and provides recommendations for addressing these issues, including requirements for resubmission and potential re-inspection of facilities.

The U.S. Food & Drug Administration (FDA) issued a Complete Response Letter for Replimune, Inc.'s Biologics License Application (BLA) for vusolimogene oderparepvec. Final approval cannot be granted due to significant clinical deficiencies in the RPL-001-16 and RP1-104 trials, which failed to provide substantial evidence of effectiveness or adequately isolate the drug's contribution, and unaddressed Chemistry, Manufacturing, and Controls (CMC) issues.

The FDA issued a Complete Response Letter for Capricor, Inc.'s Biologics License Application (BLA) for deramiocel, indicating that the application cannot be approved in its current form due to significant deficiencies in clinical data and lack of substantial evidence of effectiveness.

The U.S. Food & Drug Administration (FDA) issued a Complete Response Letter to Ultragenyx Pharmaceutical Inc. for their Biologics License Application (BLA) for rebisufligene etisparvovec. The FDA concluded that final approval cannot be granted due to deficiencies primarily related to Chemistry, Manufacturing, and Controls (CMC) and outstanding clinical data requirements.

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 218607. It outlines deficiencies in the application concerning prescribing information, carton and container labeling, proprietary name, and safety updates. The letter provides detailed instructions for addressing these deficiencies, particularly for the safety update, and sets a one-year deadline for resubmission or other actions.

This letter from the FDA outlines deficiencies in Biologics License Application (BLA) 761027, requiring the applicant to revise labeling, resubmit the proprietary name, and provide a comprehensive safety update. It also specifies the timeline and format for resubmission.

This section outlines requirements for responding to deficiencies identified during inspections and for providing a comprehensive safety update for New Drug Application (NDA) 215644. It details specific content and formatting for the safety update, including new data integration, comparative tables, and narrative summaries for adverse events and trial discontinuations.

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 210168. It reserves comment on proposed labeling until the application is otherwise adequate and outlines required actions for the applicant within one year, including resubmission or withdrawal, and emphasizes that the drug cannot be marketed until approved.

The FDA has issued a deficiency letter for NDA 217382 concerning Nutrilipid 20%. Key issues include the lack of an adequate scientific bridge between Nutrilipid 20% and Intralipid 20% due to statistically significant physicochemical differences and insufficient data on comparable drug capture capability. The application also has deficiencies in human factors validation studies, indicating unsafe user interface for critical tasks. The FDA reserves comment on proposed labeling until other issues are resolved and requests comprehensive updates to safety data, benefit-risk assessments, and clarification on the proposed indication, especially for pediatric use and non-life-threatening Local Anesthetic Systemic Toxicity (LAST).

This section serves as a representation of an electronically signed record, detailing the electronic signature and associated metadata such as the signing date, time, and a reference ID.

The FDA has identified significant deficiencies in New Drug Application (NDA) 215244 for elamipretide, concluding that its effectiveness has not been established for traditional approval due to a lack of superiority over placebo in clinical trials (SPIBA-201 Part 1 & 2, SPIBA-001) and concerns regarding bias in endpoint measurements. The proposed surrogate endpoints (LVSV, MLCL:CL ratio, acylcarnitines) are also deemed insufficient for accelerated approval due to various limitations. The FDA suggests exploring muscle strength of knee extensors as a potential intermediate clinical endpoint for accelerated approval, contingent on demonstrating its predictive clinical benefit and proposing a confirmatory postmarketing trial. Additionally, the applicant must resolve facility inspection deficiencies, and address labeling and proprietary name issues.

This FDA letter, dated April 25, 2025, addresses New Drug Application (NDA) 215818, outlining specific requirements and recommendations related to product quality, prescribing information, carton and container labeling, and other general submission procedures. It emphasizes the need for the applicant to address deficiencies, update various data points, and adhere to specific formatting and submission guidelines before the application can be approved and the product legally marketed.

This FDA letter communicates deficiencies in New Drug Application (NDA) 218353 for floretyrosine F 18, requiring the applicant to address issues related to efficacy evidence, dose optimization, prescribing information, carton and container labeling, and a comprehensive safety update. It outlines specific requirements for the safety update data presentation and sets a one-year deadline for resubmission or other actions.

This document is a Complete Response Letter (CRL) from the FDA to an applicant for New Drug Application (NDA) 218592, outlining deficiencies that prevent approval and detailing the necessary actions for resubmission.

The FDA has identified deficiencies in NDA 216442, primarily concerning the robustness of Study 030's primary efficacy endpoint analysis and the statistical methodology used. The agency requires the applicant to conduct at least one additional adequate and well-controlled study to demonstrate positive treatment effects for ocular symptoms of dry eye, without making unapproved protocol or statistical analysis plan changes. Further comments on prescribing information, carton/container labeling, and proprietary name are reserved until the application is otherwise adequate. A safety update is also required upon resubmission, and the applicant must take action within one year to resubmit or risk withdrawal of the application.

This FDA letter provides feedback on NDA 218345, acknowledging revised labeling and carton/container labeling submissions, but reserving further comment until the application is otherwise adequate. It outlines detailed requirements for a safety update, including specific data presentation and analysis, and provides instructions for resubmission or other actions within one year.

This FDA letter for NDA 218571 outlines deficiencies in the application, particularly concerning labeling and safety data, and provides instructions for resubmission and further actions required for approval.

This FDA letter outlines deficiencies and requirements for the applicant of Biologics License Application (BLA) 761377 to achieve approval. It details specific instructions for submitting revised prescribing information, carton and container labeling, proprietary name information, and a comprehensive safety update. The letter also provides guidance on the resubmission process and timelines.

This FDA letter addresses deficiencies in Biologics License Application (BLA) 761308, providing detailed instructions for revising labeling, updating safety information, and resubmitting the application. It outlines specific requirements for content, format, and timelines to achieve potential approval, emphasizing that the product cannot be marketed until written approval is received.

The FDA issued a Complete Response Letter (CRL) for NDA 216586 for rivoceranib tablets, indicating that the application cannot be approved in its present form due to outstanding issues, primarily concerning the co-dependent approval of SHR-1210 and labeling adequacy.

This FDA letter, identified as BLA 761424, outlines deficiencies in a Biologics License Application and provides detailed instructions for resubmission. It specifies requirements for updating prescribing information (labeling) to conform with regulations and guidances, and mandates a comprehensive safety update incorporating new clinical data, worldwide experience, and foreign labeling translations.

This document is a deficiency letter from the FDA regarding Biologics License Application (BLA) 761393. It outlines deficiencies related to product quality, prescribing information, proprietary name, and requires a comprehensive safety update upon resubmission. The letter also provides instructions for resubmission and potential next steps.

This section outlines the required actions for an applicant following an FDA letter regarding NDA 217719, including deadlines for resubmission or other actions, specific formatting for resubmissions, and conditions for product distribution.

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding Biologics License Application (BLA) 761290. It outlines deficiencies and provides instructions for resubmission, including requirements for labeling, proprietary name, and a comprehensive safety update. The letter also specifies the timeline and format for resubmission and notes that the product cannot be marketed until approved.

This document from the U.S. Food and Drug Administration (FDA) addresses deficiencies in New Drug Application (NDA) 219112, specifically regarding proposed labeling and the requirement for a comprehensive safety update.

The FDA has issued a Complete Response letter for Atara Biotherapeutics, Inc.'s Biologics License Application (BLA) for tabelecleucel, indicating that final approval cannot be granted due to unresolved deficiencies related to Chemistry, Manufacturing, and Controls (CMC) and inspectional observations. The FDA reserves comment on labeling until other issues are resolved.

This document outlines specific requirements and recommendations for a Biologics License Application (BLA) for a biosimilar product, focusing on the submission of updated safety data, labeling information, and proprietary name details. It emphasizes compliance with FDA regulations and guidance for biosimilar products.

This FDA letter for NDA 218879 outlines deficiencies and requirements for the applicant to address in a resubmission. It details specific instructions for revising prescribing information, updating carton and container labeling, and comprehensively presenting new safety data from clinical studies and worldwide experience. The letter also sets a one-year deadline for resubmission or other actions and clarifies the process for resubmission and potential meetings.

The FDA issued a Complete Response Letter for NDA 214697 for Neffy (epinephrine nasal spray), indicating that the application cannot be approved in its current form due to deficiencies in clinical/clinical pharmacology, product quality (nitrosamines), and requiring a comprehensive safety update, among other items.

The FDA issued a Complete Response letter for New Drug Application (NDA) 214759 for Grafapex (treosulfan) for injection, indicating that the application cannot be approved in its current form due to several deficiencies related to clinical/statistical data, prescribing information, proprietary name, safety update, and nonclinical data.

This document is a Complete Response letter from the FDA to AbbVie Inc. regarding their New Drug Application (NDA) 216962 for Vyalev (foscarbidopa and foslevodopa) injection and delivery system. The FDA has determined that the application cannot be approved in its current form due to deficiencies related to facility inspections, prescribing information, carton/container labeling, safety update requirements, and instructions for use for the associated delivery system (Vyafuser). The letter outlines specific reasons for non-approval and provides recommendations for addressing these issues.

This FDA letter, an 'Other Action Letter' for NDA 218772, informs the applicant of outstanding product quality deficiencies and outlines requirements for resubmission. It reserves comments on draft labeling and carton/container labeling until the application is otherwise approvable/adequate. The letter also addresses the proprietary name, Arbli, which is conditionally acceptable, and provides detailed instructions for a mandatory safety update to be included with the resubmission. The applicant is required to resubmit or take other actions within one year, fully addressing all identified deficiencies, and is reminded that the product cannot be legally marketed until approved.

This document is a Complete Response letter from the FDA to Tanvex BioPharma USA, Inc. for their Biologics License Application (BLA) 761126 for TX01. The FDA has determined that the application cannot be approved in its present form due to unresolved deficiencies related to facility inspections, comparative analytical assessment data, and requirements for labeling, proprietary name resubmission, and safety updates.

This is a Complete Response letter from the FDA to Akeso Biopharma Co., Ltd. regarding their Biologics License Application (BLA) for AK105 (penpulimab-kcqx). The FDA has determined that the application cannot be approved in its present form due to clinical, quality, labeling, and facility inspection deficiencies, and provides recommendations for addressing these issues.

This document is a Complete Response Letter from the FDA to Checkpoint Therapeutics, Incorporated, for their Biologics License Application (BLA) 761297 for cosibelimab (CK-301). The FDA has determined that the application cannot be approved in its present form due to unresolved facility inspection deficiencies at Samsung Biologics Co., Ltd., and concerns regarding the reliability of data generated at that facility, which impact the manufacturing process validation and characterization.

This is a Complete Response Letter from the FDA to Novo Nordisk regarding Biologics License Application (BLA) 761315 for NNC0172-2021 injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies identified in clinical and clinical pharmacology, device validation, product quality, and facility inspection.