Exhibit 99.1
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
 Food and Drug Administration Silver
Spring 
MD 20993
  NDA APPROVAL
         CONTENT OF LABELING
 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm




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http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM072392.pdf
  CARTON AND IMMEDIATE CONTAINER LABELS
   1 2 1 2




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Final Printed Carton and Container Labels
for approved NDA 021879
  EXPIRATION DATING
  REQUIRED PEDIATRIC ASSESSMENTS




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Required Pediatric
Assessments
 POSTMARKETING REQUIREMENTS UNDER 505(o)




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in vitro
      Required
Postmarketing Protocol Under 505(o), Required Postmarketing Final Report Under 505(o), Required
Postmarketing Correspondence Under 505(o)




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RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
  PROMOTIONAL MATERIALS
  
 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
 LETTERS TO HEALTH CARE PROFESSIONALS
  
 REPORTING REQUIREMENTS




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Sincerely,{See appended electronic signature page}Russell Katz, M.D. Director Division of Neurology
Products Office of Drug Evaluation I Center for Drug
Evaluation and Research




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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information
needed to use NUEDEXTA safely and effectively. See full prescribing information for NUEDEXTA.
 NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules Initial U.S. Approval: 2010
     2.1
   2.1
     3
   4.1
  4.2
  4.2
  4.3
  4.4
  4.4
  4.4
   Thrombocytopenia or other hypersensitivity reactions 5.1
  Hepatitis 5.2
  QT Prolongation 5.3
  Left ventricular hypertrophy (LVH) or left ventricular dysfunction (LVD):
  CYP2D6 substrate: 5.4 12.4
  Dizziness 5.5
  Serotonin syndrome 5.6 7.4
  Anticholinergic effects of quinidine 5.7
  6.1
 To report SUSPECTED ADVERSE REACTIONS, contact Avanir Pharmaceuticals at (1-866-388-5041) or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
   Desipramine 7.5 12.4
  Paroxetine 7.5 12.4
   Digoxin 7.6
   Pregnancy 8.1
  Pediatric Use 8.4
 See 17 for PATIENT COUNSELING INFORMATION 10/2010
  Page 1 of 19




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FULL PRESCRIBING INFORMATION: CONTENTS*1INDICATIONS AND USAGE2DOSAGE AND ADMINISTRATION2.1Recommended Dose3DOSAGE FORMS AND STRENGTHS4CONTRAINDICATIONS4.1Quinidine and related drugs4.2Hypersensitivity4.3MAOIs4.4Cardiovascular5WARNINGS AND PRECAUTIONS5.1Thrombocytopenia and Other Hypersensitivity Reactions5.2Hepatotoxicity5.3Cardiac Effects5.4Concomitant use of CYP2D6 Substrates5.5Dizziness5.6Serotonin Syndrome5.7Anticholinergic effects of quinidine5.8CYP2D6 Poor Metabolizers6ADVERSE REACTIONS6.1Clinical Trials Experience6.2Long-Term Exposure with NUEDEXTA6.3Safety Experience of Individual Components7DRUG INTERACTIONS7.1MAOIs7.2Drugs that Prolong QT and are Metabolized by CYP2D67.3Drugs that Prolong QT and Concomitant CYP3A4 Inhibitors7.4SSRIs and Tricyclic Antidepressants7.5CYP2D6 Substrate7.6Digoxin7.7Alcohol8USE IN SPECIFIC POPULATIONS8.1Pregnancy8.2Labor and Delivery8.3Nursing Mothers8.4Pediatric Use8.5Geriatric Use8.6Renal Impairment8.7Hepatic Impairment9DRUG ABUSE AND DEPENDENCE10OVERDOSAGE10.1Treatment of Overdose11DESCRIPTION12CLINICAL PHARMACOLOGY12.1Mechanism of Action12.2Pharmacodynamics12.3Pharmacokinetics12.4Drug-Drug Interactions12.5Pharmacogenomics13NONCLINICAL TOXICOLOGY13.1Carcinogenesis, Mutagenesis, Impairment of Fertility14CLINICAL STUDIES16HOW SUPPLIED/STORAGE AND HANDLING17PATIENT COUNSELING INFORMATION17.1Hypersensitivity17.2Cardiac effects17.3Dizziness17.4Drug Interactions17.5Benefits and Risks17.6Dosing Instructions17.7General




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FULL PRESCRIBING INFORMATION
 1 INDICATIONS AND USAGE
   2 DOSAGE AND ADMINISTRATION
 2.1 Recommended Dose
   3 DOSAGE FORMS AND STRENGTHS
  4 CONTRAINDICATIONS
 4.1 Quinidine and related drugs
  4.2 Hypersensitivity
 see Warnings and Precautions, (5.1)
 4.3 MAOIs
 see Drug Interactions (7.1)




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4.4 Cardiovascular
 see
Warnings and Precautions, (5.3)
 see Drug Interactions (7.2)
  5 WARNINGS AND PRECAUTIONS
 5.1 Thrombocytopenia and Other Hypersensitivity Reactions
   5.2 Hepatotoxicity
  5.3 Cardiac Effects
 see Clinical Pharmacology 12.2)




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5.4 Concomitant use of CYP2D6 Substrates
 see CYP2D6 Poor
Metabolizers (5.8), Pharmacokinetics (12.3), Pharmacogenomics (12.5) see Drug Interactions (7.5)
 5.5 Dizziness
 see Adverse Reactions (6.1)
 5.6 Serotonin Syndrome
 see Drug Interactions (7.4), Overdosage (10)
 5.7 Anticholinergic effects of quinidine
  5.8 CYP2D6 Poor Metabolizers
 see Concomitant
use of CYP2D6 substrates (5.4), Pharmacokinetics (12.3), Pharmacogenomics (12.5)
 6 ADVERSE REACTIONS




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6.1 Clinical Trials Experience
  Adverse Reactions Leading to Discontinuation
  Most Common Adverse Reactions
  Table
1: Adverse Drug Reactions with an Incidence of ≥ 3% of Patients and ≥ 2x Placebo in
NUEDEXTA-treated Patients by System-Organ Class and Preferred Term
 6.2 Long-Term Exposure with NUEDEXTA
  NUEDEXTA
    
    
    
    
    
    PlaceboN=107
    
    
    
    
    
    N=109%
    
    
    
    
    
    %Diarrhea


    
    13
    
    6Dizziness


    
    10
    
    5Cough


    
    5
    
    2Vomiting


    
    5
    
    1Asthenia


    
    5
    
    2Peripheral edema


    
    5
    
    1Urinary tract infection


    
    4
    
    1Influenza


    
    4
    
    1Increased gammaglutamyltransferase


    
    3
    
    0Flatulence


    
    3
    
    1




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6.3 Safety Experience of Individual Components
  Dextromethorphan
  Quinidine
   7 DRUG INTERACTIONS
 7.1 MAOIs
 see Contraindications (4.3)
 7.2 Drugs that Prolong QT and are Metabolized by CYP2D6
 see Contraindications (4.4)
 7.3 Drugs that Prolong QT and Concomitant CYP3A4 Inhibitors
 see Warnings and Precautions
(5.3)
 7.4 SSRIs and Tricyclic Antidepressants
 see Warnings and Precautions (5.6)
 7.5 CYP2D6 Substrate
 see Warnings and Precautions (5.4) .




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Desipramine (CYP2D6 substrate):
 Paroxetine (CYP2D6 inhibitor and substrate) 0-24 max
 7.6
    
    Digoxin
  7.7 Alcohol
  8 USE IN SPECIFIC POPULATIONS
 8.1 Pregnancy
 Pregnancy Category C
 Animal Data
 2 2




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2
 8.2 Labor and Delivery
 The effects of NUEDEXTA on labor and delivery are unknown.
 8.3 Nursing Mothers
  8.4 Pediatric Use
  8.5 Geriatric Use
  8.6 Renal Impairment
 see Clinical Pharmacology (12.3
 8.7 Hepatic Impairment
  9 DRUG ABUSE AND DEPENDENCE




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10 OVERDOSAGE
      10.1 Treatment of Overdose




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Quinidine :
 Dextromethorphan :
 11 DESCRIPTION
  18 25   2
 20 24 2 2 2  2 4  2




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12 CLINICAL PHARMACOLOGY
 12.1 Mechanism of Action
  12.2 Pharmacodynamics
 Cardiac Electrophysiology
   12.3 Pharmacokinetics
 see Concomitant use of CYP2D6 substrates (5.4), CYP2D6 Poor
Metabolizers (5.8), Pharmacogenomics (12.5)




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Absorption :
 max
 max 0-12 max 0-12
 max
  Distribution :
 Metabolism and Excretion :
   Specific Populations
 Geriatric Use




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Pediatric Use
 The pharmacokinetics of NUEDEXTA in pediatric patients have not been studied.
 Gender
  Race
  Renal Impairment
  Hepatic Impairment
  12.4 Drug-Drug Interactions
 50
 Desipramine (CYP2D6 substrate): min see CYP2D6 Substrate (5.4)




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Paroxetine (CYP2D6 inhibitor and substrate) 012 max 0-12 max 0-12 max 0-24 max
 0-24 max 012 max
 see CYP2D6 Substrate (5.4)
 NMDA receptor antagonists (memantine) N-
 12.5 Pharmacogenomics
 see Concomitant Use of CYP2D6 Substrate (5.4), CYP2D6 Poor Metabolizer (5.8),
Pharmacokinetics (12.3)
 13 NONCLINICAL TOXICOLOGY
 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
 Carcinogenesis




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2
 Mutagenesis
 in vitro
 in vitro in vivo
 in vitro in vivo in vitro
 Impairment of fertility
 2
 14 CLINICAL STUDIES




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Figure 1: Mean PBA Episode Rates by Visit
 
 
 p
 Figure 2: Least Square Mean CNS-LS Scores by Visit
  
 
 p




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16 HOW SUPPLIED/STORAGE AND HANDLING
  Package Configuration
    
    Capsule Strength (mg)
    
    NDC CodeBottles of 13 (sample)
    
    dextromethorphan 20 mg/quinidine 10 mg
    
    64597-011-13Bottles of 60 (30 day supply)
    
    dextromethorphan 20 mg/quinidine 10 mg
    
    64597-011-60
 Storage
  17 PATIENT COUNSELING INFORMATION
  17.1 Hypersensitivity
 see Contraindications (4.2), Warnings and Precautions
(5.1)
 17.2 Cardiac effects
 see Contraindications (4.4), Warnings and
Precautions 5.3) Drug Interactions (7)
 17.3 Dizziness
 see Warnings and Precautions (5.5), Adverse Reactions (6.1)
 17.4 Drug Interactions
 see Drug Interactions 7)
 17.5 Benefits and Risks




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17.6 Dosing Instructions
  17.7 General




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This is a representation of an electronic record that was signed electronically
and this page is the manifestation of the electronic signature.