FDA Letters Issued in 2023

The FDA issued a Complete Response letter for New Drug Application (NDA) 205394 for Rizaport (rizatriptan) oral film 10 mg to IntelGenx Corp., indicating that the application cannot be approved in its current form. The letter details significant deficiencies related to drug product stability, manufacturing facility inspections, and various aspects of prescribing information and carton/container labeling that must be addressed.

This document is a Complete Response letter from the FDA to InnoPharma Licensing LLC regarding their New Drug Application (NDA) 206968 for Acetaminophen Injection, 10 mg/mL. The FDA has determined that the application cannot be approved in its present form due to several deficiencies in nonclinical data, prescribing information, carton and container labeling, and the need for a safety update.

The FDA issued a Complete Response letter for Amphastar Pharmaceuticals, Inc.'s New Drug Application (NDA) 208969 for Naloxone Nasal Spray, indicating that the application cannot be approved in its present form due to several deficiencies. These include issues with the human factors validation study, pediatric safety concerns regarding product administration and absorption, unresolved manufacturing facility deficiencies, and the need for a comprehensive safety update. The letter provides recommendations for addressing these issues and outlines the process for resubmission or other actions.

This is a Complete Response letter from the FDA to scPharmaceuticals Services, Inc. for their New Drug Application (NDA) 209988 for Furoscix™ (Furosemide), a drug-device combination product. The FDA has determined that the application cannot be approved in its current form due to significant deficiencies related to device design changes, Master Access File documentation, biocompatibility testing, chemical characterization (leachables), electrical safety and electromagnetic compatibility, labeling, and human factors studies. The letter outlines specific issues and provides recommendations for addressing them.

This is a Complete Response letter from the FDA to Zhejiang Novus Pharmaceuticals Co. Ltd. regarding their New Drug Application (NDA) for Vancomycin Hydrochloride for Injection. The FDA has determined that the application cannot be approved in its present form due to unresolved objectionable conditions at the manufacturing facility, non-conformance of the proposed Prescribing Information with regulations, and a minor error in carton/container labeling. The letter outlines the deficiencies and provides recommendations for addressing them, including a detailed safety update requirement.

This document is an 'Other Action Letter' from the FDA's Center for Drug Evaluation and Research regarding NDA 211363. It outlines several deficiencies and required actions for the applicant to address, including issues with patent certification, prescribing information, and safety updates, before the application can be approved.

This document is a Complete Response Letter from the FDA to Glenmark Pharmaceuticals, Inc. regarding their New Drug Application (NDA) 211746 for GSP 301 (olopatadine HCl and mometasone furoate) 665 mcg/25 mcg Nasal Spray. The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to facility inspections, product quality, and requirements for prescribing information and safety updates.

This is a Complete Response Letter from the FDA to Fennec Pharmaceuticals, Inc. for their New Drug Application (NDA) 212937 for PEDMARK (sodium thiosulfate injection). The FDA has determined that the application cannot be approved in its current form due to product quality and safety data deficiencies, and outlines the necessary actions for resubmission.

This document is a Complete Response Letter from the FDA to an applicant for New Drug Application (NDA) 213260, indicating that the application cannot be approved in its current form due to various deficiencies. It outlines the specific issues that need to be addressed before approval can be granted, including manufacturing facility observations, product reformulation, bioequivalence studies, labeling updates, safety updates, and environmental assessment requirements.

This is a Complete Response Letter from the FDA to Azurity Pharmaceuticals, Inc. for New Drug Application (NDA) 214273 for Zonisade (zonisamide) oral suspension. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, prescribing information, carton and container labeling, medication guide, proprietary name, and safety update requirements.

This document is a Complete Response Letter from the FDA to Polarean Inc. regarding their New Drug Application (NDA) 214375 for Xenoview (xenon-129 hyperpolarized) for Inhalation. The FDA has determined that the application cannot be approved in its present form due to various deficiencies related to product quality (drug substance, drug product, device design, and reliability), prescribing information, carton and container labeling, proprietary name, and facility inspections. The letter outlines specific issues and provides recommendations for addressing them.

The FDA issued a Complete Response Letter for CorMedix Inc.'s New Drug Application (NDA) 214520 for taurolidine/heparin catheter lock solution. The application cannot be approved in its current form due to deficiencies related to product quality/facility inspections, prescribing information, carton/container labeling, and the proposed proprietary name. The letter outlines specific requirements and recommendations for addressing these issues in a resubmission.

This letter from the FDA's Center for Drug Evaluation and Research informs the applicant of NDA 214522 about required actions following an initial review. It outlines the process for resubmission or other actions, emphasizing the need to address all deficiencies and the consequences of inaction. It also provides guidance on requesting meetings and clarifies that the drug cannot be marketed until approved.

This is a Complete Response letter from the FDA to Acer Therapeutics Inc. regarding their New Drug Application (NDA) 214860 for sodium phenylbutyrate. The FDA has determined that the application cannot be approved in its current form due to several deficiencies, including an incomplete facility inspection, issues with prescribing information and labeling, and requirements for a safety update and additional nonclinical data.

This document is an 'Other Action Letter' from the FDA regarding NDA 215352. It outlines deficiencies and provides guidance on various aspects including human factors validation, prescribing information, carton and container labeling, proprietary name, and safety updates. It also specifies the actions required for resubmission and the timeline for response.

The FDA issued a Complete Response letter for NDA 215559 for palovarotene capsules, indicating that the application cannot be approved in its current form due to inadequate support for efficacy. The letter outlines major unresolved review issues, primarily concerning the efficacy data and analysis methods, and provides detailed recommendations for additional data and analyses required for resubmission.

This is a Complete Response letter from the FDA to Spes Pharmaceuticals Inc. regarding their New Drug Application (NDA) 216686 for fosaprepitant injection. The FDA has determined that the application cannot be approved in its present form due to deficiencies identified in product quality/facility inspections, prescribing information, carton and container labeling, and clinical safety data.

This is a Complete Response letter from the FDA to UCB, Inc. regarding their Biologics License Application (BLA) 761151 for UCB4940 (CDP4940). The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections and product quality. The letter outlines specific requirements for resubmission, including resolving facility inspection deficiencies, resubmitting the proprietary name, and providing a comprehensive safety update.

This document is a Complete Response Letter from the FDA to Chiesi USA regarding their Biologics License Application (BLA) 761161 for PRX-102. The FDA has determined that the application cannot be approved in its present form due to several deficiencies, including issues with manufacturing facilities, questions regarding the accelerated approval pathway given the availability of other therapies, non-conformity of proposed Prescribing Information, and requirements for a comprehensive safety update. The letter also notes that an inspection of a manufacturing facility is required but was not possible due to travel restrictions.

This is a Complete Response Letter from the FDA to Provention Bio, Inc. regarding their Biologics License Application (BLA) 761183 for PRV-031. The FDA has determined that the application cannot be approved in its present form due to various deficiencies across clinical pharmacology, product quality, facility inspections, prescribing information, and safety updates. The letter outlines specific issues and provides recommendations for addressing them.

The FDA issued a Complete Response letter for Biologic License Application (BLA) 761184 for MOD-4023 injection, indicating that the application cannot be approved in its present form. The primary reasons for non-approval include concerns regarding immunogenicity, specifically high rates of anti-drug antibody (ADA) formation and potential for cross-reactivity with other human growth hormone (hGH) products, which could lead to attenuation of effectiveness and non-responsiveness to other therapies. The FDA also noted that required facility inspections could not be completed due to travel restrictions. The letter outlines specific recommendations and requirements for the applicant to address these deficiencies.

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.

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.

The FDA issued a Complete Response Letter for Biologics License Application (BLA) 761240 for toripalimab-tpzi injection, indicating that the application cannot be approved in its current form due to deficiencies primarily related to product quality (viral safety), labeling, and safety update requirements.

This is a Complete Response Letter from the FDA to Eli Lilly and Company regarding their Biologics License Application (BLA) 761279 for LY3074828 injection for ulcerative colitis. The FDA has determined that the application cannot be approved in its current form due to deficiencies related to facility inspections, prescribing information, and the need for a comprehensive safety update.

This is a Complete Response Letter from the FDA to Azurity Pharmaceuticals, Inc. regarding their New Drug Application (NDA) 213593 for omeprazole and sodium bicarbonate for oral suspension. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to product quality, clinical data, and labeling.