TABLE OF CONTENTS - FREEDOM OF INFORMATION SUMMARY
NADA 140-872 POSILAC ® (sterile sometribove zinc suspension)

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1. General Information
2. Indications for Use
3. Dosage Form, Routes of Administration, and Recommended Dosage
4. Overview of Studies Evaluated to Provide Pivotal Effectiveness and Animal Safety Data
5. Effectiveness
   • a. Multi-location SC Dose Response Clinical Study (4 Dose-SC)
   • b. Tailhead Versus Postscapular Subcutaneous Administration Studies
6. Animal Safety
   • a. 14-Day Drug Tolerance Study (30x)
   • b. Multi-lactation Chronic Animal Toxicity Study (TAS)
   • c. Intramuscular Versus Subcutaneous Route of Injection Study (IM/SC Bridging)
   • d. Intramuscular Dose Titration Study (Dose-IM)
   • e. Multi-location Intramuscular Single Dose Study (Single Dose-IM)
   • f. Lameness
   • g. Injection Site Reactions
   • h. Nutrient Intake, Body Weight, and Body Condition Score
   • i. Reproduction
   • j. Mastitis
   • k. Cow Health
   • l. Calf Birth Traits, Growth, and Health
   • m. Miscellaneous Health Variables
     • 1) Circulating Anti-Somatotropin Binding
     • 2) Blood Variables
     • 3) Body Temperature
     • 4) Urinalysis
7. Human Safety
   • a. Drugs for Use in Food Animals
   • b. Four Week Gavage Study in Rats with Sometribove
   • c. Two Week Gavage Study in Rats with Insulin-Like Growth Factor-I (IGF-I)
   • d. Survey of Insulin-like Growth Factor-I (IGF-I) Concentrations in Individual Milk Samples from Five Missouri Dairy Herds
   • e. Survey of Insulin-Like Growth Factor-I (IGF-I} Concentrations in Commercial Bulk Tank Milk Samples
   • f. Comparison of Milk Concentrations of Insulin-Like Growth Factor-I (IGF-I) Following Subcutaneous Injections of Sometribove
   • g. Conclusions on Human Safety
8. Agency Conclusions
9. Labeling