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
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
September 28, 2017NADA 141-333Virbac AH, Inc.Sentinel® Spectrum®DogsThis supplement provides for the addition of the treatment and control of adult tapeworm (Dipylidium caninum) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.FOI Summary
July 21, 2017NADA 141-450Intervet, Inc.Banamine® TransdermalCattle/steers, beef heifers, beef cows, beef bulls intended for slaughter, and
replacement dairy heifers under 20 months of age
For the control of pyrexia associated with bovine respiratory disease and the control of pain associated with foot rot.FOI Summary
EA
FONSI
July 19, 2017NADA 141-336ECO LLCAivlosin®SwineThis supplement provides for the addition of an indication for the control of SRD.FOI Summary
July 14, 2017ANADA 200-620Aurora Pharmaceutical, LLCAltren®Horses (mares)For suppression of estrus in mares.FOI Summary
July 14, 2017ANADA 200-621Aurora Pharmaceutical, LLCSwineMate®Swine (gilts)For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle.FOI Summary

 

Page Last Updated: 02/01/2018
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