STATEMENT OF INTENT

HIGHLIGHTS

1. INDICATIONS AND USAGE

2. DOSAGE AND ADMINISTRATION

3. DOSAGE FORMS AND STRENGTHS

4. CONTRAINDICATIONS

5. WARNINGS AND PRECAUTIONS

6. ADVERSE REACTIONS

7. DRUG INTERACTIONS

8. USE IN SPECIFIC POPULATIONS

10. OVERDOSAGE

11. DESCRIPTION

12. CLINICAL PHARMACOLOGY

13. NONCLINICAL TOXICOLOGY

14. CLINICAL STUDIES

16. HOW SUPPLIED/STORAGE AND HANDLING

17. PATIENT COUNSELING INFORMATION