FDA LETTER LIBRARY

Complete response & enforcement letters

Name: FDA Complete Response & Enforcement Letters
Creator: Assyro AI
License: https://www.usa.gov/government-works

One place to review FDA responses, identify remediation themes, and open the interactive co-pilot for every letter.

Showing 169-180 of 291 letters

ALApproval Letter
Approval Letter Other 205394 (Jan 1, 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.
IssuedJan 1, 2023
US FDA• Rizaport (rizatriptan) oral film 10 mg
ALApproval Letter
Approval Letter Other 206968 (Jan 1, 2023)
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.
IssuedJan 1, 2023
US FDA• Acetaminophen Injection, 10 mg/mL
ALApproval Letter
Approval Letter Other 208969 (Jan 1, 2023)
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.
IssuedJan 1, 2023
US FDA• Naloxone Nasal Spray
ALApproval Letter
Approval Letter Other 209988 (Jan 1, 2023)
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.
IssuedJan 1, 2023
US FDA• Furoscix™ (Furosemide), 80 mg/10 mL, Drug-device combination product
ALApproval Letter
Approval Letter Other 210274 (Jan 1, 2023)
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.
IssuedJan 1, 2023
US FDA• Vancomycin Hydrochloride for Injection, 500 mg/vial, 1 gram/vial, 5 gram/vial, and 10 gram/vial
ALApproval Letter
Approval Letter Other 211363 (Jan 1, 2023)
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.
IssuedJan 1, 2023
US FDA• Unknown
ALApproval Letter
Approval Letter Other 211746 (Jan 1, 2023)
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.
IssuedJan 1, 2023
US FDA• GSP 301 (olopatadine HCl and mometasone furoate) 665 mcg/25 mcg Nasal Spray
ALApproval Letter
Approval Letter Other 212937 (Jan 1, 2023)
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.
IssuedJan 1, 2023
US FDA• PEDMARK (sodium thiosulfate injection), for intravenous use, 12.5 grams/100 mL
ALApproval Letter
Approval Letter Other 213593 (Jan 1, 2023)
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.
IssuedJan 1, 2023
US FDA• omeprazole and sodium bicarbonate for oral suspension
ALApproval Letter
Approval Letter Other 213260 (Jan 1, 2023)
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.
IssuedJan 1, 2023
US FDA• atorvastatin oral suspension
ALApproval Letter
Approval Letter Other 214273 (Jan 1, 2023)
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.
IssuedJan 1, 2023
US FDA• Zonisade (zonisamide) oral suspension, 20 mg/mL, 150 mL Fill
ALApproval Letter
Approval Letter Other 214375 (Jan 1, 2023)
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.
IssuedJan 1, 2023
US FDA• Xenoview (xenon-129 hyperpolarized) for Inhalation

Page 15 of 25

1…13 14 15 16 17…25

Approval Letter Other 205394 (Jan 1, 2023)

Approval Letter Other 206968 (Jan 1, 2023)

Approval Letter Other 208969 (Jan 1, 2023)

Approval Letter Other 209988 (Jan 1, 2023)

Approval Letter Other 210274 (Jan 1, 2023)

Approval Letter Other 211363 (Jan 1, 2023)

Approval Letter Other 211746 (Jan 1, 2023)

Approval Letter Other 212937 (Jan 1, 2023)

Approval Letter Other 213593 (Jan 1, 2023)

Approval Letter Other 213260 (Jan 1, 2023)

Approval Letter Other 214273 (Jan 1, 2023)

Approval Letter Other 214375 (Jan 1, 2023)