Approval Date: December 31, 1996
I. GENERAL INFORMATION:
Ciba Animal Health, Ciba-Geigy Corporation
P.O. Box 18300
Greensboro, NC 27419-8300
Over the Counter (OTC)
Effect of Supplement:
Change from Rx to Over the Counter and addition of an Adverse Reactions section to the product label.
II. INDICATIONS FOR USE
PROGRAM Tablets are indicated for use in dogs and puppies, six weeks of age and older, for the prevention and control of flea populations.
III. DOSAGE FORM, ROUTE OF ADMINISTRATION AND RECOMMENDED DOSAGE
The ingredients of PROGRAM Tablets are formulated into various sized tablets to be administered orally (swallow) as appropriate for the weight of the dog (see below) at monthly dosing intervals. The tablets supply the minimum recommended dose level of 10 mg lufenuron per kilogram of body weight.
|Dog Weight||No. Tablet(s) Per Month||mg Lufenuron Per Tablet||Color|
|Up to 10 lbs.||1||45.0||Brown|
|11 to 20 lbs.||1||90.0||Red|
|21 to 45 lbs.||1||204.9||Yellow|
|46 to 90 lbs.||1||409.8||White|
Dogs over 90 lbs. are provided the appropriate combination of these tablets.
The effectiveness of the product is not affected by this supplement. Refer to the FOI Summary for the original approval dated November 23, 1994.
V. ANIMAL SAFETY
The following statement has been added to the labeling, based on adverse drug experience reports.
ADVERSE REACTIONS: The following adverse reactions have been reported in dogs after giving Program tablets: vomiting, depression/lethargy, pruritus (itchy, scratchy skin), urticaria (wheals, hives), diarrhea, anorexia (loss of appetite) and skin congestion (red skin).
For additional safety information, refer to the FOI Summary for the original approval dated November 23, 1994.
VI. HUMAN SAFETY:
Data on human safety, pertaining to consumption of drug residues in food, were not required for approval of this supplement. This drug is labeled for use in dogs which are non-food animals.
VII. AGENCY CONCLUSIONS:
The product is being changed from Rx to OTC for the following reasons: 1) the condition to be treated (fleas) can be adequately diagnosed and the course of the disease (infestation) can be followed by the layperson such that an assessment can be made of the success or lack of success of the product; 2) experience with the product and other products with similar mechanisms of action demonstrates that the public is now familiar with the use of flea products which act at the level of flea egg without having an effect on the adult flea; and 3) adequate instructions for the safe and effective lay use have been written (attached).
According to the Center's supplemental approval policy (21 CFR 514.106), this is a Category II change. This supplement provides for a change in the prescription or over-the-counter status of a drug product (change from Rx to OTC) and a change in statements regarding side effects (addition of an Adverse Reactions section to the label). 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 or effectiveness data in the parent application.
VIII. LABELING (ATTACHED)
- Channel Pack--45 mg, 90 mg, 204.9 mg, and 409.8 mg
- Bulk Pack--45 mg, 90 mg, 204.9 mg, and 409.8 mg
- Dispensing Pack
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