Approval Date: April 30, 1997
I. GENERAL INFORMATION
Ivy Laboratories, Inc.
8857 Bond Street
Overland Park, KS 66214
Component™ T-S; Component™ T-H
Over the Counter (OTC)
II. TARGET ANIMAL SAFETY AND DRUG EFFECTIVENESS
Under the provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Generic Animal Drug and Patent Term Restoration Act, (53 FR 50460, December 15, 1988, First GADPTRA Policy Letter) an abbreviated new animal drug application (ANADA) may be submitted for a generic version of an approved new animal drug (pioneer product). New target animal safety data and drug effectiveness data are not required for approval of an ANADA. An ANADA relies on the target animal safety and drug effectiveness data in the pioneer's new animal drug application.
The abbreviated new animal drug application contains data from an adequate and well-controlled investigation demonstrating bioequivalence of COMPONENT™ T-S and COMPONENT™ T-H to the parent products, Finaplix®-S and Finaplix®-H, respectively. The bioequivalence study was conducted by Terry TerHune, D.V.M., Ph.D., Health Management Services, 3346 Avenue 248, Tulare, CA 93274. The purpose of the study was to demonstrate bioequivalence of COMPONENT™ T-S and COMPONENT™ T-H to Finaplix®-S and Finaplix®-H through comparison of blood serum trenbolone-17ß in steers implanted with COMPONENT™ T-S and Finaplix®-S.
Ninety-three steers were used as test animals in an 154-day study. Steers weighed an average of 469 pounds when the study was initiated. COMPONENT™ T-S and Finaplix®-S were administered subcutaneously in the middle third of the ear with the respective implanting devices.
Blood samples were collected from Day -2 through Day 0 to determine basal trenbolone-17ß levels, and from Day 63 through Day 154 at regular predetermined intervals to monitor serum levels of trenbolone-17ß by radioimmunoassay.
Natural log of area under the curve (LAUC) and natural log of maximum concentration (LCmax) of trenbolone-17ß profiles were evaluated as pivotal bioequivalence parameters. Time to maximum concentration (Tmax) was evaluated as an ancillary parameter. The parameters, LAUC and LCmax, were analyzed within a completely randomized experimental design structure with a one-way treatment structure with two treatments. Evaluation of bioequivalence parameters for COMPONENT™ T-S to the reference product, Finaplix®-S, were computed as outlined in the FDA/CVM Bioequivalence Guideline (1996).
The analysis of pivotal parameters, LAUC and LCmax, indicate blood-level bioequivalence of COMPONENT™ T-S to Finaplix®-S. Table 1 below summarize the LAUC and LCmax results for trenbolone-17ß. Tmax was analyzed nonparametrically to determine medical significance.
Table 1. Test of Bioequivalence Between COMPONENT™ T-S to Finaplix®-S Based on LAUC and LCmax
|Analysis Variable||LS Mean Component™ T-S||LS Mean Finaplix®-S||Difference||Lower 90% CI||Upper 90% CI||Component T-S % of Finaplix-S|
|LAUC||9.8124||9.8333||-0.0209||-0.1188||0.0768||88.79 to 107.98|
|LCMAX||6.7457||6.7520||-0.00627||-0.1209||0.1083||88.61 to 111.44|
III. HUMAN FOOD SAFETY
New human food safety data (other than tissue residue data) are not required for approval of an ANADA. An ANADA relies on the human food safety data in the pioneer's new animal drug application.
Allowable Incremental Increases and Safe Concentrations of Residues
The allowable incremental increases and safe concentrations established for the pioneer product apply to the generic product. The safe concentrations for total trenbolone residue in uncooked edible tissues of cattle are established under 21 CFR 556.739: 50 ppb in muscle, 100 ppb in liver, 150 ppb in kidney, and 200 ppb in fat.
When a generic product demonstrates bioequivalence to the pioneer product in a blood level study where the duration of the study exceeds the withdrawal time assigned to the pioneer product, the generic product is assigned the withdrawal time established for the pioneer product. The zero withdrawal is established for implants containing trenbolone acetate.
Regulatory Method for Residues
A regulatory method is not required because the generic product is assigned a zero withdrawal.
IV. AGENCY CONCLUSIONS
The data submitted in support of this ANADA comply with the requirements of section 512 of the Act and demonstrate that Component™ T-S and Component™ T-H are safe and effective for the indications stated on the product labeling.
Facsimile generic labeling and currently approved pioneer labeling are attached as follows:
- Box Label (Component™ T-S)
- 20 Dose Foil Pouch - Front (Component™ T-S)
- 20 Dose Foil Pouch - Back (Component™ T-S)
- Package Insert - Front (Component™ T-S)
- Package Insert - Back (Component™ T-S)
- Box Label (Component™ T-H)
- 20 Dose Foil Pouch - Front (Component™ T-H)
- 20 Dose Foil Pouch - Back (Component™ T-H)
- Package Insert - Front (Component™ T-H)
- Package Insert - Back (Component™ T-H)
- Box Label - Front (Finaplix®-S)
- Box Label - Sides (Finaplix®-S)
- Package Insert - Front (Finaplix®-S)
- Package Insert - Back (Finaplix®-S)
- Box Label - Front (Finaplix®-H
- Box Label - Right Side (Finaplix®-H)
- Box Label - Left Side (Finaplix®-H)
- Package Insert - Front (Finaplix®-H)
- Package Insert - Back (Finaplix®-H)
Copies of applicable labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855