CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for...

15
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125387Orig1s000 CROSS DISCIPLINE TEAM LEADER REVIEW

Transcript of CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for...

Page 1: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for intravitreal in ... To re-evaluate the release and shelf-life specifications for aflibercept

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

125387Orig1s000

CROSS DISCIPLINE TEAM LEADER REVIEW

Page 2: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for intravitreal in ... To re-evaluate the release and shelf-life specifications for aflibercept
Page 3: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for intravitreal in ... To re-evaluate the release and shelf-life specifications for aflibercept
Page 4: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for intravitreal in ... To re-evaluate the release and shelf-life specifications for aflibercept
Page 5: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for intravitreal in ... To re-evaluate the release and shelf-life specifications for aflibercept
Page 6: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for intravitreal in ... To re-evaluate the release and shelf-life specifications for aflibercept
Page 7: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for intravitreal in ... To re-evaluate the release and shelf-life specifications for aflibercept
Page 8: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for intravitreal in ... To re-evaluate the release and shelf-life specifications for aflibercept
Page 9: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for intravitreal in ... To re-evaluate the release and shelf-life specifications for aflibercept
Page 10: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for intravitreal in ... To re-evaluate the release and shelf-life specifications for aflibercept
Page 11: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for intravitreal in ... To re-evaluate the release and shelf-life specifications for aflibercept
Page 12: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for intravitreal in ... To re-evaluate the release and shelf-life specifications for aflibercept
Page 13: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for intravitreal in ... To re-evaluate the release and shelf-life specifications for aflibercept
Page 14: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for intravitreal in ... To re-evaluate the release and shelf-life specifications for aflibercept
Page 15: CENTER FOR DRUG EVALUATION AND RESEARCH FOR DRUG EVALUATION AND RESEARCH ... 40 m L solution for intravitreal in ... To re-evaluate the release and shelf-life specifications for aflibercept

INTRAVITREAL MICRONIZED TRIAMCINOLONE VERSUS ...s499648585.mialojamiento.es/biblioteca/IVT/Intravitreal...INTRAVITREAL MICRONIZED TRIAMCINOLONE VERSUS TRIAMCINOLONE ACETONIDE: A CLINICAL

INTRAVITREAL MICRONIZED TRIAMCINOLONE VERSUS ...s499648585.mialojamiento.es/biblioteca/IVT/Intravitreal...INTRAVITREAL MICRONIZED TRIAMCINOLONE VERSUS TRIAMCINOLONE ACETONIDE: A CLINICAL

125422Orig1s000 - Food and Drug Administration€¦ · 125422Orig1s000 MEDICAL REVIEW(S) BLA 125522 JETREA (ocriplasmin) Intravitreal Injection, 2.5 mg/mL 3 ... Reyes Candau-Chacon,

125422Orig1s000 - Food and Drug Administration€¦ · 125422Orig1s000 MEDICAL REVIEW(S) BLA 125522 JETREA (ocriplasmin) Intravitreal Injection, 2.5 mg/mL 3 ... Reyes Candau-Chacon,

Ozurdex (dexamethasone intravitreal implant) · drug-delivery system (DDS) a drug delivery system, is surgically implanted in the vitreous of the eye for sustained release ... Selection

Ozurdex (dexamethasone intravitreal implant) · drug-delivery system (DDS) a drug delivery system, is surgically implanted in the vitreous of the eye for sustained release ... Selection

FFCD 1302 EFFICACY AND SAFETY OF AFLIBERCEPT IN ...

FFCD 1302 EFFICACY AND SAFETY OF AFLIBERCEPT IN ...

EYLEA (aflibercept) Injection For Intravitreal …® (aflibercept) Injection For Intravitreal Injection ... Diabetic Macular Edema (DME) ... injection needle onto the Luer lock syringe

EYLEA (aflibercept) Injection For Intravitreal …® (aflibercept) Injection For Intravitreal Injection ... Diabetic Macular Edema (DME) ... injection needle onto the Luer lock syringe

96 Weeks Results from the VIEW 1 and VIEW 2 …VIEW 2 Studies: Intravitreal Aflibercept Injection Versus Ranibizumab for Neovascular AMD • Allen C. Ho, MD • Victor Chong, MD OBJECTIVE

96 Weeks Results from the VIEW 1 and VIEW 2 …VIEW 2 Studies: Intravitreal Aflibercept Injection Versus Ranibizumab for Neovascular AMD • Allen C. Ho, MD • Victor Chong, MD OBJECTIVE

Intravitreal Injections/Implants/media/Files/PDF/_med_guidelines/MG...Intravitreal injections into the vitreous of the eye are used to treat a variety of eye diseases. ... Intravitreal

Intravitreal Injections/Implants/media/Files/PDF/_med_guidelines/MG...Intravitreal injections into the vitreous of the eye are used to treat a variety of eye diseases. ... Intravitreal

Intravitreal Drugs

Intravitreal Drugs

SMI31 + DiONP DiONP nanoparticle injection Intravitreal Lumigan …assets.cureus.com/uploads/poster/file/350/Shih_ARVO... · 2016-03-16 · Nanoparticle Drug Delivery to Retinal Ganglion

SMI31 + DiONP DiONP nanoparticle injection Intravitreal Lumigan …assets.cureus.com/uploads/poster/file/350/Shih_ARVO... · 2016-03-16 · Nanoparticle Drug Delivery to Retinal Ganglion

PRODUCT INFORMATION EYLEA aflibercept (rch) NAME …bayerresources.com.au/resources/uploads/PI/file10294.… ·  · 2017-11-23PRODUCT INFORMATION EYLEA ® aflibercept (rch) NAME

PRODUCT INFORMATION EYLEA aflibercept (rch) NAME …bayerresources.com.au/resources/uploads/PI/file10294.… ·  · 2017-11-23PRODUCT INFORMATION EYLEA ® aflibercept (rch) NAME

Intravitreal Aflibercept Treatment of Anterior Segment ...

Intravitreal Aflibercept Treatment of Anterior Segment ...

Common Drug Review · Drug Ranibizumab (Lucentis) (10 mg/mL solution for intravitreal injection, ... health systems leaders, and policy-makers make well-informed decisions and thereby

Common Drug Review · Drug Ranibizumab (Lucentis) (10 mg/mL solution for intravitreal injection, ... health systems leaders, and policy-makers make well-informed decisions and thereby

Intravitreal in opthamology

Intravitreal in opthamology

125418Orig1s000 - Food and Drug Administration€¦ · APPLICANT: Sanofi-aventis U.S. Inc. PRODUCT: Intravenous Aflibercept INDICATION Treatment of patients with metastatic colorectal

125418Orig1s000 - Food and Drug Administration€¦ · APPLICANT: Sanofi-aventis U.S. Inc. PRODUCT: Intravenous Aflibercept INDICATION Treatment of patients with metastatic colorectal

Retinal Vein Occlusion and Diabetic Retinopathyretinatoday.com/pdfs/1009_supp.pdf · Drug delivery via intravitreal implant is not a novel concept. The first intravitreal implant

Retinal Vein Occlusion and Diabetic Retinopathyretinatoday.com/pdfs/1009_supp.pdf · Drug delivery via intravitreal implant is not a novel concept. The first intravitreal implant

Switch to Aflibercept in the Treatment of Neovascular AMD ...downloads.hindawi.com/journals/joph/2017/6835782.pdfResearch Article Switch to Aflibercept in the Treatment of Neovascular

Switch to Aflibercept in the Treatment of Neovascular AMD ...downloads.hindawi.com/journals/joph/2017/6835782.pdfResearch Article Switch to Aflibercept in the Treatment of Neovascular

Container Closure and Delivery Considerations for Intravitreal Drug Administration · 2021. 5. 6. · product label. IVT Injection Procedure Injection site for IVT administration

Container Closure and Delivery Considerations for Intravitreal Drug Administration · 2021. 5. 6. · product label. IVT Injection Procedure Injection site for IVT administration

Gold Standard Drug Monographs - WordPress.com · ADEKs Drops Adenosine Adenovirus vaccine Ado-Trastuzumab emtansine Advanced NatalCare Advanced-RF NatalCare Advera Afatinib Aflibercept

Gold Standard Drug Monographs - WordPress.com · ADEKs Drops Adenosine Adenovirus vaccine Ado-Trastuzumab emtansine Advanced NatalCare Advanced-RF NatalCare Advera Afatinib Aflibercept

Efficacy and safety of brolucizumab versus aflibercept in ...

Efficacy and safety of brolucizumab versus aflibercept in ...

Assistive Device for Efficient Intravitreal Injections · Assistive Device for Efficient Intravitreal Injections. ... drugs for the treatment of age-related ... intravitreal injections

Assistive Device for Efficient Intravitreal Injections · Assistive Device for Efficient Intravitreal Injections. ... drugs for the treatment of age-related ... intravitreal injections