Approval Date: June 11, 2003
I. GENERAL INFORMATION:
Novartis Animal Health US, Inc.
Post Office Box 26402
Greensboro, NC 27404
Program® Flavor Tabs™
Over the Counter (OTC)
Effect of Supplement:
This supplemental application provides for labeling changes reflecting the concurrent use with Capstar® (nitenpyram) Tablets (NADA 141-175) and reflecting a decrease in the minimum age from 6 weeks to 4 weeks.
II. INDICATIONS FOR USE
PROGRAM Flavor Tabs are indicated for use in dogs and puppies six weeks of age and older for the prevention and control of flea populations and in cats and kittens, six weeks of age and older for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.
III. DOSAGE FORM, ROUTE OF ADMINISTRATION AND RECOMMENDED DOSAGE
For Use in Dogs: PROGRAM Flavor Tabs are given orally, once a month, at the recommended minimum dosage of 4.5 mg/lb (10 mg/kg).
Recommended Dosage Schedule for Dogs
|Body Weight||Lufenuron Per Tablet|
|Up to 10 lbs.||45 mg|
|11 - 20 lbs.||90 mg|
|21 - 45 lbs.||204.9 mg|
|46 - 90 lbs.||409.8 mg|
Dogs over 90 lbs. are provided the appropriate combination of tablets.
For Use in Cats: PROGRAM Flavor Tabs are given orally, once a month, at the recommended minimum dosage of 13.6 mg/lb (30 mg/kg).
Recommended Dosage Schedule for Cats
|Body Weight||Lufenuron Per Tablet|
|Up to 6 lbs.||90 mg|
|7 - 15 lbs.||204.9 mg|
Cats over 15 lbs. are provided the appropriate combination of tablets.
The effectiveness of PROGRAMâ Flavor Tabsä is based upon existing Novartis product approvals for lufenuron (PROGRAMâ Tablets, NADA 141-035, PROGRAMâ Suspension, NADA 141-026). The flavoring agent used in this formulation has been adequately tested for palatability in existing Novartis product approvals (PROGRAMâ Cat Flavor Tablets, NADA 141-062, SENTINELâ Flavor Tablets, NADA 141-084).
V. ANIMAL SAFETY
The safety of PROGRAM Flavor Tabs is based upon existing Novartis product approvals for lufenuron (PROGRAM Tablets, NADA 141-035, PROGRAM Suspension, NADA 141-026).
VI. HUMAN FOOD SAFETY
Data on human safety, pertaining to consumption of drug residues in food, were not required for approval of this NADA. This drug is to be labeled for use in dogs and cats which are non-food animals.
VII. AGENCY CONCLUSIONS:
The data in support of this NADA comply with the requirements of Section 512 of the Act and Part 514 of the implementing regulations. The data demonstrate that PROGRAM Flavor Tabs (lufenuron), when used under labeled conditions of use, are safe and effective.
Because adequate directions for the safe and effective lay use of PROGRAM Flavor Tabs could be written, the product has been labeled for over-the-counter distribution.
Under section 512(c)(2)(F)(iii) of the FFDCA, this approval for non food producing animals does not qualify for marketing exclusivity because the supplemental application does not contain substantial evidence of the effectiveness of the drug involved, or any studies of animal safety required for the approval and conducted or sponsored by the applicant.
Patent # 5,416,102 expires May 2012; Patent # 5,420,163 expires May 2012; Patent # 4,798,837 expires January 2006.
VIII. LABELING (Attached)
- Package Inserts--canine, feline
- Blister Foils--45 mg, 90 mg, 204.9 mg, 409.8 mg
- Unit Dose Cartons--45 mg, 90 mg, 204.9 mg, 409.8 mg
- Display Cartons--45 mg, 90 mg, 204.9 mg, 409.8 mg
- Shipper Cartons--45 mg, 90 mg, 204.9 mg, 409.8 mg
- Reminder Stickers
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