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FDA letter monthly archive

FDA Letters Issued in January 2019

Browse FDA approval and complete response letters issued in January 2019. Each result links to a structured letter page with source PDF access, metadata, and regulatory intelligence summaries.

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 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%
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 206089 (Jan 1, 2019)

The FDA issued a Complete Response letter for Clarus Therapeutics, Inc.'s New Drug Application (NDA) for testosterone undecanoate (TU) (oral), indicating that the application cannot be approved in its present form due to several deficiencies related to safety, analytical methods, and nonclinical studies.

IssuedJan 1, 2019
US FDA• Jatenzo (testosterone undecanoate) (oral)
ALApproval Letter

Approval Letter Other 206927 (Jan 1, 2019)

This is a Complete Response letter from the FDA to Dr. Reddy's Laboratories, Limited, for New Drug Application (NDA) 206927/Original 1 for bortezomib for injection 3.5 mg/vial. The FDA has determined that the application cannot be approved in its present form and outlines specific deficiencies related to product quality, labeling, facility inspections, and safety updates, along with recommendations for addressing these issues.

IssuedJan 1, 2019
US FDA• bortezomib for injection 3.5 mg/vial
ALApproval Letter

Approval Letter Other 208193 (Jan 1, 2019)

The FDA issued a Complete Response Letter for New Drug Application (NDA) 208193 for Ozobax (baclofen) oral solution, indicating that the application cannot be approved in its current form. The letter outlines deficiencies related to product quality, including the need for additional stability studies and addressing gaps in the control strategy. It also details requirements for updating prescribing information and container labels to conform with regulatory standards, including using the SRPI checklist and submitting content in Structured Product Labeling (SPL) format. Furthermore, the applicant is required to submit a revised Initial Pediatric Study Plan (iPSP) and resubmit the proposed proprietary name. The letter provides recommendations for addressing these issues and specifies the process for resubmission or requesting a meeting.

IssuedJan 1, 2019
US FDA• Ozobax (baclofen) oral solution 1mg/mL
ALApproval Letter

Approval Letter Other 209354 (Jan 1, 2019)

The FDA issued a Complete Response Letter for NDA 209354, informing Dow Pharmaceutical Sciences, Inc. that their New Drug Application for halobetasol propionate and tazarotene lotion, 0.01%/0.045%, cannot be approved in its current form. The primary reason cited is insufficient nonclinical toxicology data, specifically a lack of an adequate bridge to listed drugs, and higher relative bioavailability of the proposed combination product. The letter outlines specific deficiencies and provides recommendations for resolution, including additional nonclinical studies and a comprehensive safety update.

IssuedJan 1, 2019
US FDA• halobetasol propionate and tazarotene lotion, 0.01%/0.045%
ALApproval Letter

Approval Letter Other 209863 (Jan 1, 2019)

The FDA issued a Complete Response letter for Antares Pharma, Inc.'s New Drug Application (NDA) 209863 for testosterone enanthate subcutaneous injection, indicating that the application cannot be approved in its current form due to identified deficiencies related to clinical safety, labeling, and other administrative aspects.

IssuedJan 1, 2019
US FDA• testosterone enanthate subcutaneous injection
ALApproval Letter

Approval Letter Other 210063 (Jan 1, 2019)

This document is a Complete Response letter from the FDA to Teva Pharmaceuticals USA, Inc. regarding their New Drug Application (NDA) 210063 for Fulvestrant Injection, 250 mg/5 mL. The FDA has determined that the application cannot be approved in its present form due to various deficiencies in nonclinical data, product quality, combination product (device) requirements, and labeling.

IssuedJan 1, 2019
US FDA• Fulvestrant Injection, 250 mg/5 mL
ALApproval Letter

Approval Letter Other 210649 (Jan 1, 2019)

This document is a Complete Response letter from the FDA to AB Pharmaceuticals, LLC, regarding New Drug Application (NDA) 210649 for Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets. The FDA has determined that the application cannot be tentatively approved in its present form due to deficiencies related to facility inspections and prescribing information.

IssuedJan 1, 2019
US FDA• Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg
ALApproval Letter

Approval Letter Other 210821 (Jan 1, 2019)

This is a Complete Response letter from the FDA to Valeant Pharmaceuticals Ireland regarding their New Drug Application (NDA) for tetracaine hydrochloride ophthalmic solution, 0.5%. The FDA has determined that the application cannot be approved in its present form due to non-compliance with current good manufacturing practice (cGMP) regulations at the manufacturing facility and issues with proposed labeling.

IssuedJan 1, 2019
US FDA• tetracaine hydrochloride ophthalmic solution, 0.5%
ALApproval Letter

Approval Letter Other 210895 (Jan 1, 2019)

This is a Complete Response letter from the FDA to Daiichi Sankyo Inc. regarding New Drug Application (NDA) 210895 for Welchol (colesevelam) chewable bar. The FDA has determined that the application cannot be approved in its present form due to product quality deficiencies related to manufacturing, and reserves comment on proposed labeling. The letter outlines specific actions required for resubmission.

IssuedJan 1, 2019
US FDA• Welchol (colesevelam) chewable bar, 3.75 grams
ALApproval Letter

Approval Letter Other 211321 (Jan 1, 2019)

This document is a Complete Response letter from the FDA to Proximagen, LLC regarding their New Drug Application (NDA) 211321 for Nayzilam (midazolam) nasal spray. The FDA has determined that the application cannot be approved in its present form due to several deficiencies, primarily related to Quality System requirements, prescribing information, labeling, and facility inspections.

IssuedJan 1, 2019
US FDA• Nayzilam (midazolam) nasal spray 5 mg/0.5 mL
ALApproval Letter

Approval Letter Other 211970 (Jan 1, 2019)

The FDA issued a Complete Response Letter for Sarepta Therapeutics' New Drug Application (NDA) 211970 for Vyondys 53 (golodirsen) injection, indicating that the application cannot be approved in its present form due to concerns regarding clinical benefit and significant safety issues, specifically serious infections related to drug delivery and renal toxicity.

IssuedJan 1, 2019
US FDA• Vyondys 53 (golodirsen) injection
ALApproval Letter

Approval Letter Other 761045 (Jan 1, 2019)

The FDA issued a Complete Response letter for Sandoz Inc.'s Biologics License Application (BLA) 761045 for LA-EP2006, a proposed biosimilar to US-licensed Neulasta. The application cannot be approved in its current form due to deficiencies in demonstrating pharmacokinetic (PK) similarity, establishing a scientific bridge between products, and various product quality issues including media fill validation, requalification strategy, microbial challenge data, container closure integrity, and simulated air transportation study data. The letter also requires a comprehensive safety update, updated labeling, and addresses pediatric presentation requirements.

IssuedJan 1, 2019
US FDA• LA-EP2006
ALApproval Letter

Approval Letter Other 761062 (Jan 1, 2019)

This is a Complete Response Letter from the FDA to Amgen Inc. regarding their Biologics License Application (BLA) for romosozumab. The FDA has determined that the application cannot be approved in its present form due to concerns about increased cardiovascular risk and requires additional data and analyses.

IssuedJan 1, 2019
US FDA• romosozumab
ALApproval Letter

Approval Letter Other 761066 (Jan 1, 2019)

This document is a Complete Response letter from the FDA to Samsung Bioepis Co., Ltd. regarding their Biologics License Application (BLA) 761066 for SB4. The FDA has determined that the application cannot be approved in its present form due to various deficiencies related to product quality, prescribing information, proprietary name, and safety updates.

IssuedJan 1, 2019
US FDA• SB4
ALApproval Letter

Approval Letter Other 761073 (Jan 1, 2019)

This is a Complete Response letter from the FDA to Amgen Inc. regarding their Biologics License Application (BLA) for Kanjinti (ABP 980). The FDA has determined that the application cannot be approved in its present form due to several deficiencies, including unresolved facility inspection issues, pending labeling revisions, and requirements for a comprehensive safety update and additional manufacturing/testing data.

IssuedJan 1, 2019
US FDA• Kanjinti (ABP 980)
ALApproval Letter

Approval Letter Other 761081 (Jan 1, 2019)

The FDA issued a Complete Response letter for Pfizer's Biologics License Application (BLA 761081) for Trazimera (PF-05280014), indicating that the application cannot be approved in its current form. The letter details numerous product quality deficiencies and provides recommendations, primarily concerning cell bank stability, drug product fill weight, shipping validation, specification controls for various attributes (ADCC, iso Asp102, high mannose, Polysorbate 20, extractable content), storage conditions, method validation, process validation, media fill data, hold time studies, and capping process parameters.

IssuedJan 1, 2019
US FDA• Trazimera (PF-05280014)
ALApproval Letter

Approval Letter Other 761085 (Jan 1, 2019)

This document is a Complete Response letter from the FDA to Evolus, Inc. regarding their Biologics License Application (BLA) 761085 for botulinum toxin Type A injection. The FDA has determined that the application cannot be approved in its present form due to various product quality, prescribing information, proprietary name, and safety update deficiencies. The letter outlines specific issues and provides recommendations for addressing them to facilitate a successful resubmission.

IssuedJan 1, 2019
US FDA• botulinum toxin Type A injection