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
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
January 29, 2018ANADA 200-622Pharmgate LLCDeccox® plus Deracin®Cattle (calves, beef, and non-lactating dairy)Decoquinate: For prevention of coccidiosis caused by Eimeria bovis and E. zuernii.
Chlortetracycline: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.
FOI Summary
January 19, 2018NADA 141-494Elanco US Inc.Credelio™DogsCredelio™ kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged 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.FOI Summary
January 16, 2018ANADA 200-563Norbrook Laboratories, Ltd.Eprizero™Beef and dairy cattle, including lactating dairy cattleFor the treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), lungworms, grubs, sucking and biting lice, chorioptic and sarcoptic mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle.FOI Summary
January 5, 2018NADA 141-449Intervet, Inc.SafeGuard® AquaSolBroiler chickens, replacement chickens, breeding chickens, and laying hensThis supplement provides for the following: 1) the addition of “and laying hens” to the indication for treatment and control of adult A. galli and H. gallinarum; 2) the removal of the limitation of “intended to become breeding chickens” from “replacement chickens” in the treatment and control portion of the A. galli only part of the indication; and 3) the removal of the limitation, “Not for use in laying hens and replacement chickens intended to become laying hens” in the indication.FOI Summary
December 12, 2017ANADA 200-617Pharmgate LLCDeracin® plus Bovatec®Cattle (fed in confinement for slaughter; pastured slaughter, stocker, feeder, dairy and beef replacement; beef; beef calves; non-lactating dairy)Chlortetracycline: For treatment of bacterial enteritis caused by Escherichia coli, treatment of bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline, and control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.
Lasalocid: For improved feed efficiency, increased rate of weight gain, and control of coccidiosis caused by Eimeria bovis and E. zuernii.
FOI Summary
December 11, 2017NADA 141-441Virbac AH, Inc.IVERHART MAX® Soft ChewDogsFor use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection and for the treatment and control of roundworms (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense), and tapeworms (Dipylidium caninum, Taenia pisiformis).FOI Summary
November 30, 2017NADA 097-505Zoetis Inc.LINCOMIX® 20 and LINCOMIX® 50SwineThis supplement modernizes the language of the previously approved indication “for reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae” to read “for reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae”; and adds a range of approved feed inclusion rates to provide for the use of lincomycin at 100 to 200 grams per ton of complete feed, fed as the sole ration for 21 consecutive days, for reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae.FOI Summary
November 21, 2017ANADA 200-473Huvepharma EOODTylovet® SolubleBroiler chickensThis supplement provides for the addition of the following indication for use in chickens: “For control of mortality caused by NE associated with Clostridium perfringens in broiler chickens.”FOI Summary
November 9, 2017NADA 106-111Zoetis Inc.Telazol®DogsThe effect of the supplement is for intravenous administration in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic.FOI Summary
October 27, 2017NADA 141-466Elanco US Inc.Inteprity™ and Maxiban™Broiler chickensFor the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens; and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima in broiler chickens.FOI Summary
October 27, 2017NADA 141-467Elanco US Inc.Inteprity™ and Monteban™Broiler chickensFor the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens; and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima in broiler chickens.FOI Summary

 

Page Last Updated: 04/02/2018
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