Assyro AI

FDA LETTER LIBRARY

Complete response & enforcement letters

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

Showing 409-420 of 493 letters

ALApproval Letter

Approval Letter Other 209575 (Jan 1, 2020)

This document is a Complete Response letter from the FDA to Lannett Holdings, Inc. regarding their New Drug Application (NDA) 209575 for Cocaine Hydrochloride Topical Solution, 4% and 10%. The FDA has determined that the application cannot be approved in its present form due to several deficiencies in clinical, nonclinical, and regulatory aspects, and provides recommendations for addressing these issues.

IssuedJan 1, 2020
US FDA• Cocaine Hydrochloride Topical Solution, 4% and 10 %
ALApproval Letter

Approval Letter Other 210583 (Jan 1, 2020)

This document is a Complete Response Letter from the FDA to Recro Pharma Inc. regarding their New Drug Application (NDA) for Meloxicam Injection. The FDA has determined that the application cannot be approved in its current form due to clinical deficiencies related to the drug's onset of action, duration of efficacy, and inadequate safety data. The letter also outlines deficiencies in carton and container labeling, and requests a comprehensive safety update upon resubmission. The applicant is advised on the process for resubmission or other actions.

IssuedJan 1, 2020
US FDA• ANJESO (meloxicam) injection, 30 mg/mL
ALApproval Letter

Approval Letter Other 210730 (Jan 1, 2020)

This is a Complete Response letter from the FDA to Trevena, Inc. regarding their New Drug Application (NDA) for Oliceridine injection. The FDA has determined that the application cannot be approved in its present form due to several deficiencies identified in clinical, nonclinical, product quality, and labeling aspects.

IssuedJan 1, 2020
US FDA• Oliceridine injection, 1 mg/mL
ALApproval Letter

Approval Letter Other 210605 (Jan 1, 2020)

The FDA issued a Complete Response letter for Mylan GmbH's New Drug Application (NDA 210605) for insulin glargine injection 100 units/mL, indicating that the application cannot be approved in its current form. Key deficiencies include unresolved objectionable conditions at the Biocon Sdn. Bhd. manufacturing facility, non-conformance of proposed Prescribing Information (PI) and Instructions for Use (IFU) with regulatory requirements, and the need for a comprehensive safety update. The letter provides detailed recommendations for addressing these issues and outlines the process for resubmission.

IssuedJan 1, 2020
US FDA• insulin glargine injection 100 units/mL
ALApproval Letter

Approval Letter Other 210875 (Jan 1, 2020)

This document is a Complete Response letter from the FDA to Sunovion Pharmaceuticals Inc. regarding their New Drug Application (NDA) 210875 for Kynmobi (apomorphine) sublingual film. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to human factors (HF) validation study, clinical pharmacology and biopharmaceutics, and safety characterization of oropharyngeal adverse events. The letter outlines specific reasons for the non-approval and provides recommendations for addressing these issues, including conducting a new HF validation study, completing a specific clinical study, and providing a comprehensive discussion and re-examination of safety data.

IssuedJan 1, 2020
US FDA• Kynmobi (apomorphine) sublingual film 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg
ALApproval Letter

Approval Letter Other 211302 (Jan 1, 2020)

This is a Complete Response Letter from the FDA to Recordati Rare Diseases Inc. regarding their New Drug Application (NDA) for Cystadrops (cysteamine ophthalmic solution) 0.37%. The FDA has determined that the application cannot be approved in its present form due to manufacturing facility compliance issues, inadequate manufacturing methods and controls, unresolved data deficiencies, and pending labeling and safety update requirements.

IssuedJan 1, 2020
US FDA• Cystadrops (cysteamine ophthalmic solution) 0.37%
ALApproval Letter

Approval Letter Other 211039 (Jan 1, 2020)

The FDA issued a Complete Response letter for NDA 211039 for fluorescein sodium and benoxinate hydrochloride ophthalmic solution, indicating that the application cannot be approved in its present form due to manufacturing facility non-compliance with current good manufacturing practice (cGMP) regulations.

IssuedJan 1, 2020
US FDA• fluorescein sodium and benoxinate hydrochloride ophthalmic solution
ALApproval Letter

Approval Letter Other 213135 (Jan 1, 2020)

This document is a Complete Response Letter from the FDA to Braintree Laboratories, Inc. regarding their New Drug Application (NDA) 213135 for SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets. The FDA has determined that the application cannot be approved in its present form due to product quality/facility inspection deficiencies, and provides recommendations for addressing these issues, including requirements for labeling, proprietary name resubmission, and a comprehensive safety update.

IssuedJan 1, 2020
US FDA• SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets
ALApproval Letter

Approval Letter Other 761115 (Jan 1, 2020)

This is a Complete Response Letter (CRL) from the FDA regarding Biologics License Application (BLA) 761115 for sacituzumab govitecan, indicating that the application cannot be approved in its present form due to various deficiencies related to product quality, manufacturing, labeling, facility inspections, and safety data.

IssuedJan 1, 2020
US FDA• sacituzumab govitecan powder for solution for infusion, intravenous, 180 mg
ALApproval Letter

Approval Letter Other 200655 (Jan 1, 2019)

The FDA issued a Complete Response letter for NDA 200655 for Fluorodopa F 18 Injection, indicating that the application cannot be approved in its current form due to significant deficiencies in clinical/statistical data, particularly regarding Study #17's design, conduct, and follow-up, which failed to provide sufficient confirmatory evidence of effectiveness. The letter also outlines requirements for labeling, safety updates, and the resubmission process.

IssuedJan 1, 2019
US FDA• Fluorodopa F 18 Injection, 0.42 mCi/mL to 8.33 mCi/ml
ALApproval Letter

Approval Letter Other 202860 (Jan 1, 2019)

This is a Complete Response letter from the FDA to Vero Biotech, LLC, for their New Drug Application (NDA) 202860 for GeNOsyl® Delivery System (Nitric Oxide). The FDA has determined that the application cannot be approved in its present form due to deficiencies identified during facility inspections, issues related to the device's design and testing (CDRH concerns), and inadequacies in the human factors validation study.

IssuedJan 1, 2019
US FDA• GeNOsyl® Delivery System (Nitric Oxide)
ALApproval Letter

Approval Letter Other 202408 (Jan 1, 2019)

This document contains multiple letters from the FDA to Fera Pharmaceuticals, LLC regarding New Drug Application (NDA) 202408 for Avaclyr (acyclovir ophthalmic ointment) 3%. It includes two 'Complete Response' letters detailing deficiencies preventing approval and required actions, and one 'Rescind Complete Response' letter indicating that a previous complete response was issued in error and the application is now under review.

IssuedJan 1, 2019
US FDA• Avaclyr (acyclovir ophthalmic ointment) 3%

Page 35 of 42

Previous
1…3334353637…42
Next