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Printable Version

NADA Number: 140-915

Proprietary Name Interceptor®
Interceptor® Flavor Tabs® for Cats
Interceptor® Flavor Tabs®
SafeHeart™
Sponsor Novartis Animal Health US, Inc.
Sponsor Address 3200 Northline Ave.
suite 300
Greensboro, NC    27408
USA
Ingredients Milbemycin Oxime
Species (Class) CATS (DOMESTIC) (Cat, excluding under 6 weeks age)
CATS (DOMESTIC) (Cat and kitten, excluding under 1.5 pounds weight)
DOGS (Dog, excluding under 2 pounds)
DOGS (Dog and puppy, excluding under 4 weeks age)
Routes of Administration Per Os
Dosage Form Tablet
Dispensing Status RX
Patent Number (Expiration Date) 4547520 (No Expiration Date)
Exclusivity Granted for separate dosage and labeling for cats.
Granted for the prescription only use of the product for removal and control of adult Toxocara canis (roundworm) and Trichuris vulpis (whipworm) infections in dogs over 8 weeks of age. The product is currently approved for prevention of heartworm disease caused by Dirofilaria immitis and control of hookworm infections caused by Ancylostoma caninum.
Granted for a lower dosage for use in dogs.
Treatment of heartworm disease in puppies 4 weeks and older or greater than 2 pounds.
Granted for adding a lower dosage for use in the prevention of heartworm disease in dogs and puppies and a new tradename. The original conditions of approval for Interceptor? under NADA 140-915 remain unchanged.
Specifications

Each tablet contains 2.3, 5.75, 11.5, or 23.0 milligrams of milbemycin oxime.


Dosage Amount,
Indications
& Limitations

Dogs (and puppies)

Amount: For hookworm, roundworm, and whipworm, use 0.23 milligram per pound of body weight (0.5 milligram per kilogram). For heartworm, use 0.05 milligram per pound of body weight (0.1 milligram per kilogram).

Indications: For prevention of heartworm disease caused by Dirofilaria immitis, control of hookworm infections caused by Ancylostoma caninum, and removal and control of adult roundworm infections caused by Toxocara canis and Toxascaris leonina and whipworm infections caused by Trichuris vulpis in dogs and in puppies 4 weeks of age or greater and 2 pounds of body weight or greater. Limitations: Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight. Administer once a month. First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats (and kittens)

Amount: 0.91 milligram per pound of body weight (2.0 milligrams per kilogram).

Indications: For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infections in cats 6 weeks of age or greater and 1.5 pounds body weight or greater. Limitations: Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of a licensed veterinarian.