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FDA letter monthly archive

FDA Letters Issued in January 2018

Browse FDA approval and complete response letters issued in January 2018. Each result links to a structured letter page with source PDF access, metadata, and regulatory intelligence summaries.

ALApproval Letter

Approval Letter Other 202158 (Jan 1, 2018)

This is a Complete Response letter from the FDA to NorthStar Medical Radioisotopes, LLC regarding their New Drug Application (NDA) 202158 for TechneGen Generator System for Preparation of Sodium Pertechnetate Tc99m Injection. The FDA has determined that the application cannot be approved in its present form due to multiple deficiencies identified in clinical aspects (labeling, user manuals, training, human factor testing), product quality microbiology (sterility assurance, microbiological control, process validation, cleaning protocols, sterilization confirmation, manufacturing information), deficiencies in a referenced Drug Master File (DMF), and inadequate manufacturing facility inspections.

IssuedJan 1, 2018
US FDA• TechneGen Generator System for Preparation of Sodium Pertechnetate Tc99m Injection, (Sodium Pertechnetate Tc99m Injection USP) Injection
ALApproval Letter

Approval Letter Other 205920 (Jan 1, 2018)

This is a Complete Response letter from the FDA to Armstrong Pharmaceuticals, Inc. regarding their New Drug Application (NDA) 205920 for Primatene Mist (epinephrine inhalation aerosol). The FDA has determined that the application cannot be approved in its present form, primarily due to deficiencies in the human factors (HF) study which failed to demonstrate safe and effective use of the product for proposed over-the-counter (OTC) use. The letter outlines specific reasons for non-approval and provides detailed recommendations for addressing these issues, including further HF studies, labeling revisions, and a safety update.

IssuedJan 1, 2018
US FDA• Primatene Mist (epinephrine inhalation aerosol), 125 mcg per spray
ALApproval Letter

Approval Letter Other 206185 (Jan 1, 2018)

This document is a Complete Response letter from the FDA to Sun Pharma Advanced Research Company Limited regarding their New Drug Application (NDA) for Xelpros (latanoprost ophthalmic emulsion), 0.005%. The FDA has determined that the application cannot be approved in its present form due to unresolved deficiencies related to manufacturing facilities and requires a comprehensive safety update.

IssuedJan 1, 2018
US FDA• Xelpros (latanoprost ophthalmic emulsion), 0.005%
ALApproval Letter

Approval Letter Other 206976 (Jan 1, 2018)

This document is an 'Other Action Letter' from the FDA regarding New Drug Application (NDA) 206976, outlining deficiencies that need to be addressed before the application can be approved. It details specific requirements related to biopharmaceutics, quality control, labeling, proprietary name, and safety updates.

IssuedJan 1, 2018
US FDA• Licart
ALApproval Letter

Approval Letter Other 207962 (Jan 1, 2018)

This is a Complete Response Letter from the FDA to Scilex Pharmaceuticals, Inc. regarding their New Drug Application (NDA) 207962 for ZTlido (lidocaine patch 1.8%). The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to regulatory, clinical, clinical pharmacology, and nonclinical aspects.

IssuedJan 1, 2018
US FDA• ZTlido (lidocaine patch 1.8%)
ALApproval Letter

Approval Letter Other 207987 (Jan 1, 2018)

This is a Complete Response Letter from the FDA to Belcher Pharmaceuticals, LLC, for their New Drug Application (NDA) 207987 for Ablysinol (Dehydrated Alcohol Injection, USP). The FDA has determined that the application cannot be approved at the present time due to various deficiencies related to clinical data, product quality (CMC), prescribing information, proprietary name, and facility inspections. The letter outlines specific issues and provides suggestions for addressing them, including a mandatory postmarketing study.

IssuedJan 1, 2018
US FDA• Ablysinol (Dehydrated Alcohol Injection, USP)
ALApproval Letter

Approval Letter Other 208042 (Jan 1, 2018)

This is a Complete Response letter from the FDA to Teva Pharmaceuticals USA regarding their New Drug Application (NDA) 208042 for buprenorphine and naloxone sublingual film. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspection, prescribing information, Medication Guide, Risk Evaluation and Mitigation Strategy (REMS), and safety update requirements.

IssuedJan 1, 2018
US FDA• buprenorphine and naloxone sublingual film, 16 mg/4 mg
ALApproval Letter

Approval Letter Other 208276 (Jan 1, 2018)

The FDA issued a Complete Response letter for New Drug Application (NDA) 208276 for the Implantable System for Remodulin (treprostinil) solution for injection, indicating that the application cannot be approved in its current form. The primary reasons for non-approval include the device component not being approvable, insufficient human factors data for safe and effective use, and insufficient data regarding the risk of microbial contamination in the implantable pump system.

IssuedJan 1, 2018
US FDA• Implantable System for Remodulin (treprostinil) solution for injection
ALApproval Letter

Approval Letter Other 208288 (Jan 1, 2018)

The FDA issued two Complete Response letters for New Drug Application (NDA) 208288 for SoluPrep™ to 3M Health Care. The letters detail reasons for non-approval, including nonclinical deficiencies related to impurity qualification and systemic toxicity assessment, requirements for a comprehensive safety update, and clinical deficiencies regarding replicative efficacy in pivotal studies and insufficient financial disclosure information for subinvestigators. The application cannot be approved in its present form, and specific actions are required for resubmission.

IssuedJan 1, 2018
US FDA• SoluPrep™ (2% chlorhexidine gluconate and 70% isopropyl alcohol), solution
ALApproval Letter

Approval Letter Other 208313 (Jan 1, 2018)

The FDA issued a Complete Response letter to Sun Pharmaceutical Industries Limited for their New Drug Application (NDA) for INFUGEM (gemcitabine injection), indicating that the application cannot be approved in its present form due to deficiencies identified during facility inspections and issues related to clinical data presentation and labeling.

IssuedJan 1, 2018
US FDA• INFUGEM (gemcitabine injection)
ALApproval Letter

Approval Letter Other 208564 (Jan 1, 2018)

The FDA issued a Complete Response letter for NDA 208564 for estradiol vaginal insert, indicating that the application cannot be approved in its current form due to deficiencies primarily related to clinical safety data, particularly long-term endometrial safety, and issues with labeling, safety updates, chemistry, manufacturing, controls, and carton/container labeling.

IssuedJan 1, 2018
US FDA• estradiol vaginal insert, 4, 10, mcg
ALApproval Letter

Approval Letter Other 209311 (Jan 1, 2018)

This document is a Complete Response letter from the FDA to Ironshore Pharmaceuticals & Development, Inc. regarding their New Drug Application (NDA) 209311 for Jornay PM (methylphenidate hydrochloride) Modified Release Capsules. The FDA has determined that the application cannot be approved in its present form due to clinical safety concerns, specifically a high rate of insomnia, and outlines deficiencies and recommendations for resubmission.

IssuedJan 1, 2018
US FDA• Jornay PM (methylphenidate hydrochloride) Modified Release Capsules, 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg
ALApproval Letter

Approval Letter Other 209191 (Jan 1, 2018)

This document contains two Complete Response letters from the FDA to Hospira, Inc. regarding their New Drug Application (NDA) 209191 for Bortezomib for Injection. Both letters state that the application cannot be approved in its current form and outline deficiencies that need to be addressed for resubmission. The first letter (dated February 22, 2018) primarily focuses on product quality (elemental impurities), labeling, and safety update requirements. The second letter (dated November 3, 2017, though appearing later in the text) highlights deficiencies found during a manufacturing facility inspection, in addition to similar labeling and safety update requirements.

IssuedJan 1, 2018
US FDA• Bortezomib for Injection, 2.5 mg/vial
ALApproval Letter

Approval Letter Other 208742 (Jan 1, 2018)

This document is a Complete Response letter from the FDA to Ocular Therapeutix, Inc. regarding their New Drug Application (NDA) 208742 for DEXTENZA (dexamethasone ophthalmic insert). The FDA has determined that the application cannot be approved in its current form due to deficiencies related to product quality/facilities inspection, prescribing information, proprietary name, and safety updates. The letter outlines specific issues and provides recommendations for addressing them.

IssuedJan 1, 2018
US FDA• DEXTENZA (dexamethasone ophthalmic insert), 0.4 mg
ALApproval Letter

Approval Letter Other 761039 (Jan 1, 2018)

This document is a Complete Response Letter from the FDA to Coherus BioSciences, Inc. regarding their Biologics License Application (BLA) 761039 for CHS-1701. The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to immunogenicity, product quality, prescribing information, proprietary name, and safety updates. The letter outlines specific issues and provides recommendations for addressing them.

IssuedJan 1, 2018
US FDA• CHS-1701
ALApproval Letter

Approval Letter Other 761088 (Jan 1, 2018)

This is a Complete Response letter from the FDA to CELLTRION, Inc. regarding their Biologics License Application (BLA) 761088 for the proposed biosimilar product CT-P10. The FDA has determined that the application cannot be approved in its current form due to deficiencies identified in facility inspections, clinical data, product quality, and other regulatory aspects. The letter outlines specific issues and provides recommendations for addressing them prior to resubmission.

IssuedJan 1, 2018
US FDA• CT-P10
ALApproval Letter

Approval Letter Other 761091 (Jan 1, 2018)

This document is a Complete Response letter from the FDA to CELLTRION, Inc. regarding their Biologics License Application (BLA) for CT-P6. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, product quality, and the need for an updated safety profile.

IssuedJan 1, 2018
US FDA• CT-P6
ALApproval Letter

Approval Letter Other 208647 (Jan 1, 2018)

This document is a Complete Response letter from the FDA to Salamandra, LLC regarding New Drug Application (NDA) 208647 for rosuvastatin capsules. 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 update requirements.

IssuedJan 1, 2018
US FDA• rosuvastatin capsules, 5mg, 10mg, 20mg, and 40mg