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  • ClinPharmR

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    Jagdish Chander
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    022122_ClinPharmR

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    6 views64 pages

    ClinPharmR

    Uploaded by

    Jagdish Chander
    Article

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 64
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22-122 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) CLINICAL PHARMACOLOGY REVIEW NDA: 22-122 Submission Type; Code: Brand/Code Name: Generic Name: Primary Reviewer: OND Division: Sponsor: Relevant IND(s): Formulation; Strength(s): Proposed Indication: Proposed Dosage Regimen: Table of Contents 1 Executive Summat 14 Recommendations 2 1.2 Phase IV Commitments Submission Date: 12/19/06 Is Voltaren Topical Gel Diclofenac Na Topical Gel 1% David Lee, Ph.D. ‘Suresh Doddapaneni, Ph.D. pep 2 Anesthesia, Analgesia, and Rheumatology Products Novartis Consumer Health, Inc 64,334 1% diclofenac Na gel ——— _ jjoims amenable to [~ treatment, such as hands and knees Lower extremities, including the knees, ankles, and feet: Apply the gel (4 g) tothe affected joi, 4 times daily. Voltaren should be gently massaged into the skin ensuring pplication to the entire affected joint. Do not use more than 16 g daily per lower joint. Upper extremities including the elbows, wrists and hands: Apply the gel (2) to the affected joint, 4 times daly. Voltaren® should be gently massaged int the skin ensuring application to the entire affected joint. Do not use more than 8 ally per upper join. Total usage should not exceed 32 g per day, over all affected joints. 2 1.3 Summary of CPB Findings . 2 2 gee. 6 24 General Attributes of the Drug 6 2.1.1 What are the highlights of the chemistry and physical-chemical properties of the

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