Animal & Veterinary

Recent Animal Drug Approvals


Drug Approval Information

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


DateApplication NumberSponsorProduct NameSpeciesIndications for Use/Effect of the SupplementPublic Documents
July 30, 2018ANADA 200-608Piedmont Animal HealthBaytril® Soft Chewable TabletsDogs and catsFor the management of diseases associated with bacteria susceptible to enrofloxacin.FOI Summary
July 13, 2018NADA 141-406Merial, Inc.NexGard®DogsThis supplement provides for the addition of the indication for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.FOI Summary
July 13, 2018ANADA 200-484Huvepharma EOODTylovet® 40Beef Cattle and SwineThis supplemental approval provides for the addition of a 40 g/lb strength of this Type A medicated article.FOI Summary
July 11, 2018NADA 138-952Elanco US Inc.Maxiban™ 72Broiler chickensThis supplement revises the tissue residue tolerance for nicarbazin from 4 ppm to 52 ppm, and reduces the withdrawal period for Maxiban™ 72 from five days to zero days.

FOI Summary

EA

FONSI

July 6, 2018ANADA 200-495Norbrook Laboratories, Ltd.Enroflox® 100SwineThe effect of the supplement provides for the addition of the use of the drug via intramuscular injection in swine, the addition of two pathogens, Bordetella bronchiseptica and Mycoplasma hyopneumoniae, to the swine respiratory disease (SRD) treatment and control indications and the addition of indications for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.FOI Summary
July 2, 2018ANADA 200-624Modern Veterinary Therapeutics, LLCREVERTIDINE™DogsFor the reversal of the sedative and analgesic effects of dexmedetomidine
hydrochloride, and medetomidine hydrochloride in dogs.
FOI Summary
June 14, 2018NADA 098-379Merial, Inc.CYSTORELIN®Lactating dairy cows and beef cowsThis supplement provides for the addition of a new indication ‘For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows and beef cows.’

FOI Summary

EA

FONSI

June 6, 2018NADA 141-342Jurox Pty. Ltd.Alfaxan® MultidoseCats and DogsThis supplement provides for the addition of preservatives to the formulation and use of a multidose vial.FOI Summary
May 31, 2018NADA 141-495Elanco US Inc.Inteprity™ and Bio-Cox®Broiler chickensFor the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens; and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati in broiler chickens.FOI Summary
May 25, 2018NADA 141-063Intervet, Inc.Nuflor®Cattle (beef and non-lactating dairy)This supplement provides information to address the human food safety of N-methyl-2-pyrrolidone (NMP) in the formulation of Nuflor® injectable solution in cattle.FOI Summary
May 15, 2018NADA 141-501Boehringer Ingelheim Vetmedica, Inc.Semintra®CatsFor the control of systemic hypertension in cats.FOI Summary
May 4, 2018NADA 141-481Kindred Biosciences, Inc.Mirataz™CatsFor the management of weight loss in cats.FOI Summary
April 25, 2018NADA 141-454AquaBounty Technologies, Inc.AquAdvantage SalmonAtlantic SalmonThis supplement provides for an additional grow-out facility in Indiana for AquAdvantage Salmon.

EA

FONSI

March 26, 2018NADA 141-491Zoetis Inc.Coban™ and LINCOMIX®Broiler chickensAs an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens.FOI Summary
March 8, 2018NADA 141-492Merial, Inc.Centragard™CatsFor the prevention of heartworm disease caused by Dirofilaria immitis, and for the treatment and control of roundworms (adult and fourth stage larval Toxocara cati), hookworms (adult and fourth stage larval Ancylostoma tubaeforme; adult Ancylostoma braziliense), and tapeworms (adult Dipylidium caninum and Echinococcus multilocularis), in cats and kittens 7 weeks of age and older and 1.8 lbs or greater.FOI Summary
March 5, 2018NADA 141-489Zoetis Inc.Zoamix® and LINCOMIX®Broiler chickensFor the prevention and control of coccidiosis, and for the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens.FOI Summary
March 2, 2018NADA 141-484Zoetis Inc.Bio-Cox® and LINCOMIX®Broiler chickensFor the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens.FOI Summary
February 28, 2018NADA 141-483Zoetis Inc.Deccox® and LINCOMIX®Broiler chickensFor the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, and E. brunetti, and for the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens.FOI Summary
February 28, 2018NADA 141-482Zoetis Inc.Robenz® and LINCOMIX®Broiler chickensAs an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix, and for the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens.FOI Summary

 

Page Last Updated: 08/02/2018
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