Oral Dosage Form New Animal Drugs; Lufenuron Tablets; Milbemycin Oxime and Lufenuron Tablets; Nitenpyram Tablets

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The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two original new animal drug applications (NADAs) and three supplemental NADAs filed by Novartis Animal Health US, Inc. The original NADAs provide for the concurrent oral use in dogs of approved milbemycin oxime and lufenuron flavor tablets with nitenpyram tablets to kill adult fleas and prevent flea eggs from hatching and for the concurrent oral use in dogs and cats of approved lufenuron flavor tablets with nitenpyram tablets to kill adult fleas and prevent flea eggs from hatching. The supplemental NADAs provide appropriate labeling for the concurrent uses of the individual products and, for lufenuron flavor tablets, use in puppies and kittens as young as 4 weeks of age.