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
November 21, 2018NADA 038-439Phibro Animal Health Corp.Terramycin® 100 for Fish and Terramycin® 200 for FishFreshwater-reared salmonids weighing up to 55 gramsFreshwater-reared salmonids weighing up to 55 grams: For marking the skeletal tissue.FOI Summary
November 9, 2018NADA 141-502Zoetis Inc.revolution® PLUSCatsrevolution® PLUS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis. revolution® PLUS kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the treatment and control of tick infestations with Ixodes scapularis (black-legged tick), Amblyomma maculatum (Gulf Coast tick) and Dermacentor variabilis (American dog tick), the treatment and control of ear mite (Otodectes cynotis) infestations, and the treatment and control of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections for one month in cats and kittens 8 weeks and older, and weighing 2.8 pounds or greater.FOI Summary
November 6, 2018NADA 141-508Elanco US Inc.Experior™Beef steers and heifers fed in confinement for slaughterFor reduction of ammonia gas emissions per pound of live weight and hot carcass weight in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.

FOI Summary

EA

FONSI

November 1, 2018ANADA 200-627Putney, Inc.Cyclosporine Capsules, USP MODIFIEDDogsCyclosporine Capsules, USP MODIFIED are indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.FOI Summary
October 15, 2018NADA 141-485Zoetis Inc.COYDEN® and LINCOMIX®Broiler chickensAs an aid in the prevention of cecal and intestinal coccidiosis caused by E. 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
October 1, 2018ANADA 200-490Dragon Fire Holding Co., Inc.CarprofenDogsFor 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
August 10, 2018NADA 141-488Zoetis Inc.Avatec® and LINCOMIX®Broiler chickensFor the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, 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
August 9, 2018ANADA 200-630Aurora Pharmaceutical, LLCCocciAid™Growing chickens, turkeys and laying hensFor the treatment of coccidiosis.FOI Summary
August 8, 2018NADA 141-439Elanco US Inc.Inteprity™Broiler chickensThis supplement provides for a change in the broiler chicken age restriction caution statement from 10 days to 18 days as follows: To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age.

FOI Summary

EA

FONSI

August 3, 2018NADA 141-461Aratana Therapeutics, Inc.NOCITA®CatsThis supplement provides for use as a peripheral nerve block to provide regional postoperative analgesia following onychectomy in cats.FOI Summary
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

 

Page Last Updated: 12/03/2018
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