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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
July 29, 2020 ANADA 200-687 Cronus Pharma Specialities India Private Ltd. Carprofen Chewable Tablets Dogs For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs. FOI Summary
July 27, 2020 NADA 141-538 Ceva Sante Animale Cardalis™ Dogs With concurrent therapy (e.g., furosemide, etc.) for the management of clinical signs of mild, moderate, or severe congestive heart failure in dogs due to atrioventricular valvular insufficiency (AVVI). FOI Summary
July 9, 2020 NADA 141-532 Intervet, Inc. BRAVECTO® 1-MONTH Dogs 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), Dermacentor variabilis (American dog tick) and Rhipicephalus sanguineus (brown dog tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater.
It is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for one month in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater.
FOI Summary
June 18, 2020 NADA 141-535 Zoetis, Inc. Aureo S 700® and Bovatec® Beef steers and heifers fed in confinement for slaughter; and beef cattle up to
800 lbs
1) As an aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever, and for improved feed efficiency in beef steers and heifers fed in confinement for slaughter.
2) As an aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever, and for improved feed efficiency and increased rate of weight gain in beef steers and heifers fed in confinement for slaughter.
3) As an aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever, and for control of coccidiosis caused by Eimeria bovis and E. zuernii in beef cattle up to 800 lbs.
FOI Summary
June 15, 2020 NADA 141-534 Orion Corp. CLEVOR® Dogs For the induction of vomiting in dogs. FOI Summary
June 4, 2020 ANADA 200-399 Huvepharma EOOD CycleGuard® 500 Cattle/Beef Heifers Heifers Fed in Confinement for Slaughter: For increased rate of weight gain, improved feed efficiency and suppression of estrus (heat). 
Heifers Intended for Breeding: For suppression of estrus (heat).
FOI Summary
June 2, 2020 ANADA 200-682 Huvepharma EOOD Vetmulin® 12.5% Swine Vetmulin® 12.5% (tiamulin hydrogen fumarate), when administered in the drinking water for five consecutive days, is an effective antibiotic 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
June 1, 2020 ANADA 200-134 Intervet, Inc. FERTAGYL® Beef cows This supplement provides for the addition of a new target animal subclass, beef cows, to the existing estrous synchronization indication. FOI Summary
May 27, 2020 ANADA 200-638 Vetoquinol USA, Inc. IMOXI™ Topical Solution for Cats Cats For the prevention of heartworm disease caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations. It is also indicated for the treatment and control of ear mite (Otodectes cynotis) infestations and the following intestinal parasites: adult, immature adult, and fourth stage larvae in hookworms (Ancylostoma tubaeforme); and adult and fourth stage larvae in roundworm (Toxocara cati). FOI Summary
May 21, 2020 ANADA 200-680 Felix Pharmaceuticals Pvt. Ltd. Enrofloxacin Flavored Tablets Dogs and cats For the management of diseases associated with bacteria susceptible to enrofloxacin in dogs and cats. FOI Summary
May 14, 2020 ANADA 200-679 Huvepharma EOOD Optigrid® 45 Cattle fed in confinement for slaughter Complete Feed: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
Top Dress Feed: For increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
FOI Summary
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

 

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