Novartis Animal Health US Inc.’s Sentinel Spectrum (milbemycin oxime/lufenuron/praziquantel) Tablets received U.S. Food and Drug Administration approval, the agency reported today.
Sentinel Spectrum is indicated for the prevention of heartworm disease and the prevention and control of flea populations, adult whipworms and adult tapeworms in dogs and puppies two pounds of body weight or greater and six weeks of age and older.
The new product adds the anthelmintic praziquantel to the existing Sentinel formula, allowing for treatment and control of tapeworms. The FDA approval qualifies Novartis for three years of marketing exclusivity of the drug through Dec. 8, 2014.
The FDA approved Sentinel Spectrum tablets in the ratio of 0.5 mg milbemycin oxime, 10 mg lufenuron and 5 mg of praziquantel per kilogram of the dog’s body weight, once a month. It was approved in four configurations, including:
- 2.3 mg milbemycin oxime, 46 mg lufenuron and 22.8 mg praziquantel;
- 5.75 mg milbemycin oxime, 115 mg lufenuron and 57 mg praziquantel;
- 11.5 mg milbemycin oxime, 230 mg lufenuron and 114 mg praziquantel; or
- 23 mg milbemycin oxime, 460 mg lufenuron, and 228 mg praziquantel.
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