GADA Quarterly Meeting July 16, 2009

1. GADA Quarterly MeetingJuly 16, 2009 Dr. Ken Harshman, Director Division of Generic Animal Drugs

2. Bioequivalence Data Submissions • Required components: • Signed Report: Study Director, Sponsor, QA • Study report • Index • Paginated • Appendices • Copy of protocol • Study data • Statistical analysis • Analytical methods - full validation report • Raw data, chromatographs, etc.

3. Palatability Study • Information presented October 23, 2008, is still applicable • Palatability criteria for new animal drugs has changed • Substantial evidence constitutes palatability testing in a field study with at least 100 animals • Future labels will contain only factual information from substantial evidence studies • Will discontinue the 70% palatability standard • Term “Flavored”, “Chew” or “Chewable” can be used regardless of testing results • Adequate directions for use will address variability in drug acceptance • Generics will not be held to a higher standard

4. Dissolution Study • Acceptance Criteria = f2>50 f2 = • Reflects the average difference in the percent dissolved • Test design • 12 dissolution profiles for each strength • Sampling times – one point at 15 min. and sample out to 85% of test and reference product dissolution • Test criteria: compare the various strengths of test drug against the strength used in bioequivalence study • Recommend also comparing the corresponding strengths of the test and reference drug

5. Dissolution Study Considerations • If all test product comparisons meet f2 criteria, biowaiver is granted • If one or two strengths fail in test drug comparisons; compare against the same strength of reference drug • Can use this information to support waiver as long as the two strengths used in BE study are comparable in vitro • Require another BE for each strength that fails in vitro comparisons • All data on all strengths of test and reference drug must be submitted at the same time • Analytical method for measuring drug concentration must be validated

6. Claims of Categorical Exclusion • Generic Investigational New Animal Drug • After opening a JINAD submit a claim • X submission • Review/letter done by Environmental Team • Appropriate language: In compliance with 21 CFR 25.15, we claim that the investigational use of <drug> identified in this generic investigational new animal drug (JINAD) file qualifies for categorical exclusion under 21 CFR 25.33(e) from the requirement to prepare an environmental assessment. We also confirm that to our knowledge no extraordinary circumstances exist as described in 21 CFR 25.21 that may significantly affect the quality of the human environment.

7. Claims of Categorical Exclusion • Environmental Technical Section • Phased review process • P submission • Review/letter done by Generics • Appropriate language: In compliance with 21 CFR 25.15, we claim that the approval of this abbreviated new animal drug application (ANADA) qualifies for categorical exclusion under 21 CFR 25.33(a)(1) from the requirement to prepare an environmental assessment. The approval will not increase the use of the drug. We also confirm that to our knowledge no extraordinary circumstances exist as described in 21 CFR 25.21 that may significantly affect the quality of the human environment.