PMF 005-042 - Effectiveness Letter
March 25, 2011
Attention: Meg Oeller, DVM
FDA Liaison to the NRSP-7
Center for Veterinary Medicine
7500 Standish Place
Rockville, MD 20855
Re: Effectiveness technical section complete
Dear Dr. Oeller:
Based upon the information you submitted on July 1, 2010, and amended on July 20, 2010 (T-0014), October 25, 2010 (T-0015), and January 24, 2011 (T-0016) and the information contained in the investigational new animal drug (INAD) file I-009096, we consider the Effectiveness technical section to be complete. The technical section is complete for the use of AVATEC (lasalocid) Type A Medicated Article for the control of coccidiosis associated with Eimeria spp. in pheasants.
We have the following comments:
- We re-analyzed your data for the oocyst counts, average weight gain, and daily droppings scores. The results of our analysis are documented in the draft Freedom of Information (FOI) Summary language enclosed with this letter.
For oocyst counts, we used non-parametric Wilcoxon rank sum test to compare the uninoculated, unmedicated group and the inoculated, unmedicated group; and a general linear model to analyze the inoculated, unmedicated group and the lasalocid-treated group data. For average weight gain, we used a general linear model and mean contrasts were performed to compare the means of the uninoculated, unmedicated group and the inoculated, unmedicated group; For droppings scores, we re-analyzed the total dropping score of uninoculated, unmedicated group and inoculated, unmedicated group using non-parametric Wilcoxon two-sample test. We also re-analyzed the inoculated, medicated group and the lasalocid-treated group data using general linear model. All tests were conducted using a two-sided 0.05 significance level.
- You initially submitted the study without any electronic data or program. The data files received after several weeks were not clearly named and were not in a form that would allow us to recreate the statistical tests. There were also missing labels and typographical errors.
In any future submissions, please provide all the data and program files to read and analyze the data on electronic media. The data should be in a form that will allow us to recreate the statistical tests you have done and should include all the data labels and file descriptions. Please also double check your report documents and minimize as much as possible the occurrence of typographical errors to facilitate our review of your submission.
FREEDOM OF INFORMATION (FOI) SUMMARY
We appreciate your cooperation in including the relevant portions of the FOI Summary with this submission. The Effectiveness section of the FOI Summary has been revised, and a copy is enclosed. Please review the FOI Summary for accuracy and notify us if you find errors. If you request changes other than the correction of errors, CVM may re-open the Effectiveness technical section. CVM will prepare the final version of the FOI Summary and will provide you a copy when the last technical section is complete.
You did not submit draft labeling with the Effectiveness technical section. Please submit your Labeling technical section, containing any additional information not previously submitted, when the last major technical section has been submitted and is likely to be complete.
ALL OTHER INFORMATION
You did not submit All Other Information with this submission. Please submit your All Other Information technical section, containing any additional information not previously submitted, when the last major technical section has been submitted and is likely to be complete.
Include a copy of this technical section complete letter when you submit your new animal drug application. Please contact us if there are changes in the product development plan (e.g., indication, dosage, duration of use) or you become aware of any issues that may impact the status of this technical section or your application. We will make a final decision on whether we can approve your application after we have reviewed all of the data for all applicable technical sections and any other information available to us, as a whole, and determined whether the requirements for approval described in the Federal Food, Drug, and Cosmetic Act have been met.
If you submit correspondence relating to this letter, your correspondence should reference the date and the principal submission identifier found at the top of this letter. If you have any questions or comments, please contact me at (240) 276-8341. You may also contact Dr. Michelle Kornele, Acting Leader, Antiparasitic and Physiologic Drugs Team, at (240)-276-8355.
Cindy Burnsteel, DVM
Director, Division of Therapeutic
Drugs for Food Animals
Office of New Animal Drug Evaluation
Center for Veterinary Medicine
Draft Freedom of Information Summary (Effectiveness)