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  1. Approved Animal Drug Products (Green Book)

Recent Animal Drug Approvals

Drug Approval Information

Approved Animal Drug Products (Green Book Online)
Animal Drugs@FDA
Freedom of Information (FOI) Summaries for Approved New Animal Drugs (FOI Summary)
Environmental Assessments/Findings of No Significant Impact (EA/FONSI)
NSAID Labels
Medicated Feed (Blue Bird) Labels

Date Application Number Sponsor Product Name Species Indications for Use/Effect of the Supplement Public Documents
April 27, 2020 ANADA 200-674 Modern Veterinary Therapeutics, LLC Detomidine Hydrochloride Horses For use as a sedative and analgesic to facilitate minor surgical and diagnostic procedures in mature horses and yearlings. FOI Summary
April 22, 2020 ANADA 200-673 Aurora Pharmaceutical, Inc. Revolt™ Dogs and cats For use in dogs six weeks of age or older and cats eight weeks of age and older for the following parasites and indications:
Dogs: Kills adult fleas and prevents flea eggs from hatching for one month and is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and the treatment and control of ear mite (Otodectes cynotis) infestations. It is also indicated for the treatment and control of sarcoptic mange (Sarcoptes scabiei) and for the control of tick infestations due to Dermacentor variabilis.
Cats: Kills adult fleas and prevents flea eggs from hatching for one month and is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and the treatment and control of ear mite (Otodectes cynotis) infestations. It is also indicated for the treatment and control of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections in cats.		 FOI Summary
April 10, 2020 NADA 141-533 Boehringer Ingelheim Animal Health USA, Inc. Aservo® EquiHaler® Horses For the management of clinical signs associated with severe equine asthma in horses. FOI Summary
April 2, 2020 NADA 141-527 Bayer HealthCare LLC, Animal Health Division Baytril® 100-CA1 Cattle: replacement dairy heifers under 20 months of age and all classes of
beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age); not for use in any other class of dairy cattle or in veal calves		 Conditionally approved for the treatment of clinical anaplasmosis associated with Anaplasma marginale in replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age). Not for use in any other class of dairy cattle or in veal calves. FOI Summary
March 27, 2020 NADA 141-322 Zoetis Inc. Improvest® Gilts intended for slaughter This supplement provides for the addition of the indication for the temporary suppression of estrus in gilts intended for slaughter. FOI Summary
March 23, 2020 ANADA 200-586 Dechra Veterinary Products LLC Marboquin™ Dogs and cats For the treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin. FOI Summary
March 10, 2020 ANADA 200-670 Chanelle Pharmaceuticals Manufacturing Ltd. SENERGY™ Dogs and cats Recommended for use in dogs six weeks of age or older and cats eight weeks of age and older for the following parasites and indications:
Dogs: Kills adult fleas and prevents flea eggs from hatching for one month and is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and the treatment and control of ear mite (Otodectes cynotis) infestations. It is also indicated for the treatment and control of sarcoptic mange (Sarcoptes scabiei) and for the control of tick infestations due to Dermacentor variabilis.
Cats: Kills adult fleas and prevents flea eggs from hatching for one month and is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and the treatment and control of ear mite (Otodectes cynotis) infestations. It is also indicated for the treatment and control of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections in cats.		 FOI Summary
February 27, 2020 NADA 141-521 Zoetis Inc. Simparica Trio™ Dogs Simparica Trio™ prevents heartworm disease caused by Dirofilaria immitis, kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick), and the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and adult hookworm (Ancylostoma caninum and Uncinaria stenocephala) infections for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. FOI Summary
February 7, 2020 ANADA 200-614 Akorn Animal Health, Inc. Pentobarbital Sodium and Phenytoin Sodium Dogs For use in dogs for humane, painless, and rapid euthanasia. FOI Summary
January 28, 2020 NADA 141-466 Elanco US Inc. Inteprity™ and Maxiban™ Broiler chickens This supplement approval provides for 1) a change in the broiler chicken age restriction caution statement from 10 days to 18 days of age as follows: To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age; and, 2) an update to the withdrawal periods and residue warnings statement as follows: No withdrawal period is required when used according to labeling. Do not feed to chickens producing eggs for human consumption. FOI Summary
December 30, 2019 NADA 013-076 Elanco US Inc. Tylan™ Soluble Honey bees This supplement provides for the establishment of a tolerance of 500 ppb for residues of tylosin in honey. FOI Summary
December 30, 2019 NADA 008-622 Zoetis Inc. Terramycin®
Terramycin® Soluble Powder Concentrate
Terramycin-343®		 Honey bees This supplement provides for the establishment of a tolerance of 750 ppb for the sum of tetracycline residues  in honey. FOI Summary
December 20, 2019 NADA 111-636 Zoetis Inc. LINCOMIX® Soluble Powder Honey bees This supplement provides for the establishment of a tolerance of 750 parts per billion (ppb) for residues of lincomycin in honey. FOI Summary
December 19, 2019 ANADA 200-615 Vetoquinol USA, Inc. IMOXI™ Topical Solution for Dogs Dogs For the prevention of heartworm disease caused by Dirofilaria immitis and the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs. Kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis). For the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis. For the treatment and control of intestinal roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum and Uncinaria stenocephala), and whipworms (Trichuris vulpis). FOI Summary
December 9, 2019 ANADA 200-546 Bimeda Animal Health Ltd. BimaGard™ 12.5% Swine For the treatment of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin at a dose level of 3.5 mg tiamulin hydrogen fumarate per pound of body weight daily and for treatment of swine pneumonia due to Actinobacillus pleuropneumoniae susceptible to tiamulin when given at 10.5 mg tiamulin hydrogen fumarate per pound of body weight daily. FOI Summary
December 9, 2019 NADA 141-528 Elanco US Inc. Credelio™ CAT Cats Kills adult fleas, and for the treatment and prevention of flea infestations (Ctenocephalides felis) for one month in cats and kittens 8 weeks of age and older and weighing 2.0 pounds or greater. FOI Summary
November 25, 2019 NADA 141-513 Kindred Biosciences, Inc. Zimeta™ Horses For the control of pyrexia in horses FOI Summary
November 20, 2019 ANADA 200-663 Norbrook Laboratories, Ltd. Selarid™ Dogs and cats For dogs 6 weeks of age and older: Kills adult fleas and prevents flea eggs from hatching for 1 month, and it is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and treatment and control of ear mite (Otodectes cynotis) infestations. Treatment and control of sarcoptic mange (Sarcoptes scabiei) and control of tick infestations due to Dermacentor variabilis.
For cats 8 weeks of age and older: Kills adult fleas and prevents flea eggs from hatching for 1 month, and it is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and treatment and control of ear mite (Otodectes cynotis) infestations. Treatment and control of intestinal hookworm (Ancylostoma tubaeforme) and roundworm (Toxocara cati) infections.		 FOI Summary
November 14, 2019 NADA 141-518 Intervet, Inc. BRAVECTO® PLUS Cats For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage larvae, immature adults, and adults) and hookworm (Ancylostoma tubaeforme, 4th stage larvae, immature adults, and adults); kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations (Ixodes scapularis (black-legged tick)) and Dermacentor variabilis (American dog tick)) for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater. FOI Summary