Anada 200-22

FREEDOM OF INFORMATION SUMMARY
COMPONENT TE-S (Trenbolone Acetate and Estradiol)

1. GENERAL INFORMATION
Trenbolone Acetate, Estradiol, and Tylosin Tartrate Effect of Supplement: This supplement provides for the addition of a tylosin tartrate pellet as a local antibacterial to Component® TE-S. 2. INDICATIONS FOR USE

For increased rate of weight gain and improved feed efficiency in feedlot steers.
3. DOSAGE FORM(S), ROUTE OF ADMINISTRATION, AND RECOMMENDED
DOSAGE

Dosage Form: Implantation
Route of Administration: Subcutaneous implantation on the posterior aspect of the
middle one-third of the ear by means of an implant gun.
Recommended Dosage: One implant containing 120 mg trenbolone acetate, 24 mg
estradiol, and 29 mg tylosin tartrate.

4. EFFECTIVENESS

The effectiveness requirement for this supplemental new animal drug application, with
the indications for use and dosage as given in Sections 2 and 3 above, is met by utilizing
the information contained in ANADA 200-221 and conducting the additional adequate
and well-controlled study included in this supplemental application.
Pivotal Study:

A study was conducted by William Barton, CAVL, Inc, Amarillo,TX, to evaluate the
effectiveness of Component® E-S with Tylan® to lower the incidence of ear abscess
formation. An implant site abscess induction model was developed to reliably create a
high abscess rate in test animals. This model was used to test the ability of a tylosin
tartrate pellet to reduce implant site abscess incidence in animals expected to develop an
ear abscess. In the study, 40 beef steers were subjected to the abscess-inducing culture at
the same time they were implanted with either Component® TE-S with a Tylan® pellet or
Component® TE-S alone. Implant sites were observed at regular intervals up to 35 days
following implantation. Abscess rate at each time point was significantly lower
(P<0.0001) in animals treated with Component® TE-S with a Tylan® pellet compared to
animals treated with Component® TE-S alone, with the maximum incidence of abscesses
of 5% and 100%, respectively.

5. TARGET ANIMAL SAFETY

Target animal safety of Component® TE-S is established by data in the parent
application. The data provided in the effectiveness study described above was sufficient
to conclude that the use of the tylosin pellet was safe for use in cattle. No further studies
were required.
6. HUMAN SAFETY
Human safety is established for Component® TE-S by data in the parent application. No further studies were required for use of the tylosin pellet. 7. AGENCY CONCLUSIONS

Adequate data demonstrates the safe and effective use of a tylosin tartrate pellet added to Component® TE-S as a local antibacterial. Under the Center's supplemental approval policy (21 CFR 514.106(b)(2)), this is a Category II change providing for the addition of a tylosin tartrate pellet as a local antibacterial to Component® TE-S. The approval of this change is not expected to have any adverse effect on the safety or effectiveness of this new animal drug. Accordingly, this approval did not require a reevaluation of the safety and effectiveness data in the parent application. 8. LABELING

Facsimile labeling is attached as follows: 1. Component® TE-S with Tylan® Box Label 2. Component® TE-S with Tylan® 20 Dose Foil Pouch 3. Component® TE-S with Tylan® Package Insert

Source: http://www.betterchem.com/vet/cvm_foi/section3/200-221s072099.pdf