VALCHLORgel0.016%(氮芥外用软有)药品审评(FDA)
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CENTER FOR DRUG EVALUATIONAND
RESEARCH
APPLICATION NUMBER:
202317Orig1s000
MEDICAL REVIEW(S)
CLINICAL REVIEW
Application Type
Application Number(s)
Priority or Standard
Submit Date(s)
Received Date(s)
PDUFA Goal Date
Division/Office
Reviewer Name(s)
Review Completion Date
Established Name
(Proposed)Trade Name
Therapeutic Class
Applicant
Formulation(s)
Dosing Regimen
Indication(s)
Intended Population(s)
NDA 505(b)(2)
202317
Class 2 Resubmission
27 February 2013
27 February 2013
27 August 2013
DHP/OHOP
R.Angelo de Claro,M.D.
25 June 2013
Mechlorethamine
Valchlor
Antineoplastic
Ceptaris Therapeutics,Inc.
0.016%gel
Topical,once daily
CTCL Stage IA and IB,
second-line therapy
Adults ≥18 years
Template Version:March 6,2009
Reference ID:3331209
Clinical Review
R. Angelo de Claro , M.D.
NDA 202317
Valchlor ( Mechlorethamine gel)
Table of Contents
1 RECOMMENDATIONS /RISK BENEFIT ASSESSMENT ............................................... 5
1.1 Recommendation on Regulatory Action ......................................................................... 5
1.2 Risk Benefit Assessment ................................................................................................... 5
1.3 Recommendations for Postmarket Risk Evaluation and Mitigation Strategies ... 7
1.4 Recommendations for Postmarket Requirements and Commitment ..................... 7
2 INTRODUCTION AND REGULATORY BACKGROUND ............................................... 7
3 ETHICS AND GOOD CLINICAL PRACTICES ...................................................................
8
3.1 Submission Quality and Integrity ..................................................................................... 8
3.2 Compliance with Good Clinical Practices....................................................................... 8
3.3 Financial Disclosures........................................................................................................... 8
4 SIGNIFICANT EFFICACY /SAFETY ISSUES RELATED TO OTHER REVIEW
DISCIPLINES ...............................................................................................................................
8
4.1 Chemistry Manufacturing and Controls.............................................................................
8
4.2 Clinical Microbiology ...........................................................................................................
9
4.3 Preclinical Pharmacology /Toxicology............................................................................... 9
4.4 Clinical Pharmacology...........................................................................................................9
5 SOURCES OF CLINICAL DATA ........................................................................................... 9
5.1 Tables of Studies /Clinical Trials ....................................................................................... 9
5.2 Review Strategy ................................................................................................................... 9
5.3 Discussion of Individual Studies /Clinical Trials.............................................................. 9
6 REVIEW OF EFFICACY...............................................................................................................
9
Efficacy Summary ...........................................................................................................................
9
7 REVIEW OF SAFETY ............................................................................................................. 10
Safety Summary ........................................................................................................................... 10
7.1 Methods.................................................................................................................................. 11
7.2 Adequacy of Safety Assessments................................................................................... 11
7.3 Major Safety Results ..........................................................................................................11
8 POSTMARKET EXPERIENCE ............................................................................................... 11
9 APPENDICES ........................................................................................................................... 12
9.1 Literature Review /References ....................................................................................... 12
9.2 Labeling Recommendation .............................................................................................. 12
9.3 Advisory Committee Meeting........................................................................................... 13
2
Reference ID:3331209
摘要：
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CENTERFORDRUGEVALUATIONANDRESEARCHAPPLICATIONNUMBER:202317Orig1s000MEDICALREVIEW(S)CLINICALREVIEWApplicationTypeApplicationNumber(s)PriorityorStandardSubmitDate(s)ReceivedDate(s)PDUFAGoalDateDivision/OfficeReviewerName(s)ReviewCompletionDateEstablishedName(Proposed)TradeNameTherapeuticClassApplicant...
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作者：冒牌货
分类：专业资料
价格：100质量币
属性：132 页
大小：1.21MB
格式：PDF
时间：2026-01-13
