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22450 Acetaminophen__Clinica CLINICAL REVIEW Application Type NDA Submission Number 22-450 Submission Code N000 Letter Date May 13, 2009, June 23, 2009, June 26, 2009 Stamp Date May 15, 2009, June 23, 2009, June 26, 2009 PDUFA Goal Date November 13, 2009 Reviewer Name Christina Fang, M.D., M.P.H. Review Completion Date October 17, 2009 Established Name Acetaminophen IV injection (Proposed) Trade Name (b) (4) Therapeutic Class Analgesic and antipyretic Applicant Cadence Pharmaceuticals, Inc. Priority Designation 3P Formulation IV solution containing acetaminophen (10 mg/mL) Dosing Regimen 1 g every 6 hours or 650 mg every 4 hours in adults 7.5-15 mg/kg by age and body weight in pediatric Indication Acute pain and fever Intended Population Hospitalized patients TABLE OF CONTENTS 1. RECOMMENDATIONS/RISK BENEFIT ANALYSIS ..................................................................................................................4 1.1 RECOMMENDATION ON REGULATORY ACTION........................................................................................................................4 1.2 RISK BENEFIT ANALYSIS .........................................................................................................................................................4 1.3 RECOMMENDATIONS FOR POSTMARKETING RISK MANAGEMENT ACTIVITIES.........................................................................6 1.4 RECOMMENDATION FOR OTHER POSTMARKETING STUDY COMMITMENTS ..............................................................................6 2. INTRODUCTION AND REGULATORY BACKGROUND ..........................................................................................................7 2.1 PRODUCT INFORMATION..........................................................................................................................................................7 2.2 CURRENTLY AVAILABLE TREATMENT(S) FOR PROPOSED INDICATION(S)................................................................................7 2.3 AVAILABILITY OF PROPOSED ACTIVE INGREDIENT IN THE UNITED STATES ............................................................................7 2.4 IMPORTANT ISSUES WITH CONSIDERATION TO RELATED DRUGS.............................................................................................9 2.5 SUMMARY OF PRESUBMISSION REGULATORY ACTIVITY RELATED TO THIS SUBMISSION ........................................................9 2.6 OTHER RELEVANT BACKGROUND INFORMATION ..................................................................................................................10 3. ETHICS AND GOOD CLINICAL PRACTICES...........................................................................................................................11 3.1 SUBMISSION QUALITY AND INTEGRITY .................................................................................................................................11 3.2 COMPLIANCE WITH GOOD CLINICAL PRACTICES ...................................................................................................................11 3.3 FINANCIAL DISCLOSURES ......................................................................................................................................................11 4. SIGNIFICANT EFFICACY OR SAFETY FINDINGS RELATED TO OTHER REVIEW DISCIPLINES ...........................12 4.1 CHEMISTRY MANUFACTURING AND CONTROLS ....................................................................................................................12 4.2 CLINICAL MICROBIOLOGY (IF APPLICABLE) ..........................................................................................................................12 4.3 PRECLINICAL PHARMACOLOGY/TOXICOLOGY.......................................................................................................................12 4.4 CLINICAL PHARMACOLOGY...................................................................................................................................................12 4.4.1 Mechanism of Action.......................................................................................................................................................12 4.4.2 Pharmacodynamics ..........................................................................................................................................................12 4.4.3 Pharmacokinetics .............................................................................................................................................................12 5. SOURCES OF CLINICAL DATA AND REVIEW STRATEGY.................................................................................................14 5.1 TABLES OF CLINICAL STUDIES ..............................................................................................................................................14 5.2 REVIEW STRATEGY................................................................................................................................................................15 5.3 DISCUSSION OF INDIVIDUAL STUDIES ....................................................................................................................................15 5.3.1 (b) (4) .............................................................................................................................................................15 5.3.1.1 Protocol .......................................................................................................................................................................15 5.3.1.2 Results.........................................................................................................................................................................18 5.3.1.3 Summary of Findings and Discussion.........................................................................................................................26 5.3.1.4 Conclusion...................................................................................................................................................................27 5.3.1.5 Appendix.....................................................................................................................................................................28 5.3.2 (b) (4) .............................................................................................................................................................29 5.3.2.1 Protocol .......................................................................................................................................................................29 5.3.2.2 Results.........................................................................................................................................................................32 5.3.2.3 Summary of Findings and Discussion.........................................................................................................................39 5.3.2.4 Conclusion...................................................................................................................................................................40 5.3.2.5 Appendix.....................................................................................................................................................................41 5.3.3 (b) (4) .................................................................................................................................................42 5.3.3.1 Protocol .......................................................................................................................................................................42 5.3.3.2 Results.........................................................................................................................................................................44 5.3.3.3 Summary of Findings and Discussions .......................................................................................................................48 5.3.3.4 Conclusion...................................................................................................................................................................48 5.3.4 Other efficacy studies.......................................................................................................................................................50 5.3.4.1 Additional analgesic studies........................................................................................................................................50 5.3.4.2 Additional antipyretic study ........................................................................................................................................51 5.3.4.3 Pediatric studies...........................................................................................................................................................52 5.3.4.4 Conclusion...................................................................................................................................................................52 6. INTEGRATED REVIEW OF EFFICACY .....................................................................................................................................53 SUMMARY OF EFFICACY RESULTS AND CONCLUSIONS ........................................................................................................................53 6.1 PROPOSED INDICATION..........................................................................................................................................................53
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