Animal & Veterinary
NADA 110-315 Implus-C® - supplemental approval (January 22, 1997)
Approval Date: January 22, 1997
I. GENERAL INFORMATION
|Sponsor:||Ivy Laboratories, Inc.|
8857 Bond Street
Overland Park, KS 66214
|Generic Name:||progesterone and estradiol benzoate|
|Marketing Status:||Over the Counter (OTC)|
|Effect of Supplement:||This supplement provides for the deletion of the present labeling limitation against the use of Implus-C in heifer (suckling beef) calves intended for reproduction.|
II. INDICATIONS FOR USE
For increased rate of weight gain in suckling beef calves up to approximately 400 lbs body weight.
A. DOSAGE FORM: Implantation
B. ROUTE OF ADMINISTRATION: Subcutaneous implantation on the posterior aspect of the middle one-third of the ear by means of an implant gun.
C. RECOMMENDED DOSAGES: One implant containing 100 mg progesterone and 10 mg estradiol benzoate
This supplement providing for the deletion of the present labeling limitation against the use of Implus-C in heifer (suckling beef) calves intended for reproduction does not affect the effectiveness information contained in the current NADA.
V. ANIMAL SAFETY
A target animal safety study was conducted under a similar protocol by Dr. Larry Corah, Kansas State University, Manhattan, KS at the following locations: Finegan Ranch, Bingham, NE; Gates Ranch, Coldwater, KS; KSU/Hays Experiment Station, Hays, KS; KSU/ASI, Manhattan, KS; Bar S Ranch, Paradise, KS; and Thielen Ranch, Dorrance, KS. The purpose of the study was to evaluate the effect of Implus-C implants administered to suckling heifer calves on their subsequent reproductive performance. At all six locations, suckling heifer calves were stratified by body weight and randomly assigned to one of three treatment groups. Heifers were either implanted with a single dose of Implus-C at 45-120 days of age (Early Implant Group), implanted with a single dose of Implus-C at 6-8 months of age (Late Implant Group), or were not implanted (Control Group). At approximately 15 months of age, the heifers were bred by AI during a 60-day breeding season. Heifers that became pregnant were allowed to calve the following spring.
The following table shows the mean values for each of the parameters recorded during the study:
|Dose Groups (mg/hd/day)|
|Items||Control Group||Early Group||Late Group|
|Age at Onset of Puberty (days)||382.8||383.7||383.4|
|% Cycling at Breeding||86.5||81.4||84.3|
|Pelvic Area (cm)||167.9||181.7||175.2|
|First Service Conception Rate (%)||56.5||58.2||55.1|
|Services/Conception - Pregnant Heifers||1.1||1.1||1.1|
|Pregnancy Rate (%)||83.2||83.6||84.3|
|Calving Rate (%)||78.9||79.8||80.9|
|Abortion Rate (%)||5.2||4.6||4.0|
|Age of Heifer at Calving (days)||725.9||725.2||724.0|
|Calving Ease Score||1.3||1.3||1.3|
|Heifer Initial Weight (lb)||235.2||232.3||236.6|
|Heifer Weaning Weight (lb)||551.7||565.4||553.4|
|Heifer Prebreeding Weight (lb)||748.9||763.1||756.6|
|Calf Birth Weight (lb)||72.1||73.1||74.0|
|Calf Weaning Weight (lb)||478.2||489.7||476.7|
|% Calves Weaned||94.5||95.9||93.0|
No differences were observed between any of the treatment groups for the parameters measured in the study. All treatment groups had comparable values for each parameter measured. The data demonstrates that any difference in calving rate between the treatment groups would be less than 10%. Accordingly, the data provides adequate evidence that IMPLUS-C had no adverse effect on subsequent reproduction when administered to heifer (suckling beef) calves after 45 days of age through 6-8 months of age.
VI. HUMAN FOOD SAFETY
This supplement providing for the deletion of the present labeling limitation against the use of Implus-C in heifer (suckling beef) calves intended for reproduction does not affect the human food safety information contained in the current NADA.
VII. AGENCY CONCLUSIONS
Adequate data were provided to demonstrate that IMPLUS-C had no adverse effect on subsequent reproduction when administered to heifer (suckling beef) calves after 45 days of age.
Under the Center's supplement approval policy (21 CFR 514.106(b)(2)), this is a Category II change providing for the deletion of the labeling limitation against the use of IMPLUS-C in heifer (suckling beef) calves intended for reproduction. 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.
Under section 512(c)(2)(F)(iii) of the FFDCA, this approval for food producing animals qualifies for THREE years of marketing exclusivity beginning on the date of approval because the supplemental application contains substantial evidence of the effectiveness of the drug involved, any studies of animal safety, or, in the case of food producing animals, human food safety studies (other than bioequivalence or residue studies) required for the approval of the application and conducted or sponsored by the applicant. The three years of marketing exclusivity applies only to the change in the labeling (deletion of the present labeling limitation against the use of Implus-C in heifer (suckling beef) calves intended for reproduction) for which the supplemental application was approved.
VIII. LABELING (Attached)
Twelve (12) pages of labeling are attached as follows:
- Foil Pouch Containing 20 Doses - Front Panel
- Foil Pouch Containing 20 Doses - Back Panel
- Carton Containing 5 Cartridge Belts of 20 Doses Each - Front Panel
- Carton Containing 5 Cartridge Belts of 20 Doses Each - Back Panel
- Carton Containing 5 Cartridge Belts of 20 Doses Each - Side Panel
- Carton Containing 5 Cartridge Belts of 20 Doses Each - End Panel
- 400 Dose Display Case - Front Panel
- 400 Dose Display Case - Back Panel
- 400 Dose Display Case - Top Panel
- 400 Dose Display Case - Side Panel
- Package Insert for 20 Dose Cartridge Belt - Front Panel
- Package Insert for 20 Dose Cartridge Belt - Back Panel
Copies of applicable labels may be obtained by writing to the:
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.