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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  1. Approved Animal Drug Products (Green Book)

Recent Animal Drug Approvals

On October 20, 2024, CVM began implementing a reorganization impacting two of our offices. We are in the process of updating FDA.gov content to reflect these changes.

Drug Approval Information

Approved Animal Drug Products (Green Book Online)
Animal Drugs@FDA
Freedom of Information (FOI) Summaries for Approved and Conditionally Approved Animal Drugs (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
December 19, 2024NADA 141-043Zoetis Inc.SYNOVEX Choice and SYNOVEX PRIMER (trenbolone acetate and estradiol benzoate implants)Growing beef steers and heifers on pasture (stocker, feeder, and slaughter)This supplement provides for the approval of a new indication for increased rate of weight gain in growing beef steers and heifers on pasture (stocker, feeder, and slaughter) to SYNOVEX Choice; and provides for the approval of a new indication for increased rate of weight gain in growing beef steers and heifers on pasture (stocker, feeder, and slaughter) to SYNOVEX
PRIMER.		FOI Summary
November 25, 2024NADA 141-532Intervet, Inc.BRAVECTO 1-MONTH (fluralaner)DogsThis supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (Asian longhorned tick) infestations for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater.FOI Summary
November 22, 2024NADA 141-452Zoetis Inc.SIMPARICA (sarolaner)DogsThis supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (Asian longhorned tick) infestations for one month in dogs 6 months of age or older and weighing 2.8 pounds or greater.FOI Summary
November 20, 2024ANADA 200-636Bimeda Animal Health Ltd.DORACIDE (doramectin topical solution)CattleFor the treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and sucking lice, horn flies, and mange mites in cattle.FOI Summary
November 18, 2024ANADA 200-805Virbac AH, Inc.MEL 500 (melengestrol acetate Type A liquid medicated article)Cattle (heifers fed in confinement for slaughter and heifers intended for
breeding)		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
November 18, 2024ANADA 200-793Parnell Technologies Pty. Ltd.PropofolVet Multidose (propofol injectable emulsion)DogsFor induction of anesthesia. For maintenance of general anesthesia by intermittent bolus injections for short procedures. For induction of general anesthesia where maintenance is provided by inhalant anesthetics.FOI Summary
November 14, 2024ANADA 200-803Phibro Animal Health Corp.PAQFLOR (florfenicol)Freshwater-reared salmonids, freshwater-reared finfish, catfish, and
freshwater-reared warmwater finfish		Freshwater-reared salmonids: For the control of mortality due to furunculosis associated with Aeromonas salmonicida. For the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum. 
Freshwater-reared finfish: For the control of mortality due to columnaris disease associated with Flavobacterium columnare. 
Catfish: For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri. 
Freshwater-reared warmwater finfish: For the control of mortality due to streptococcal septicemia associated with Streptococcus iniae.		FOI Summary
November 13, 2024NADA 141-502Zoetis Inc.revolution PLUS (selamectin and sarolaner topical solution)CatsThis supplement provides for the addition of the indication for the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated cat for one month in cats and kittens 8 weeks and older, and weighing 2.8 pounds or greater.FOI Summary
November 6, 2024NADA 141-521Zoetis Inc.SimparicaTRIO (sarolaner, moxidectin, and pyrantel chewable tablets)DogsThis supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (Asian longhorned tick) infestations for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater.FOI Summary
October 25, 2024NADA 141-590Elanco US Inc.MGA and Experior and Rumensin (melengestrol acetate Type A medicated article and lubabegron Type A medicated article and monensin Type A medicated article)Growing beef heifers fed in confinement for slaughterFor increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), for reduction of ammonia gas emissions per pound of live weight and hot carcass weight, and for the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii in growing beef heifers fed in confinement for slaughter during the last 14 to 91 days on feed.FOI Summary
October 25, 2024NADA 141-591Elanco US Inc.MGA and Experior and Rumensin and Tylan (melengestrol acetate Type A medicated article and lubabegron Type A medicated article and monensin Type A medicated article and tylosin phosphate Type A medicated article)Growing beef heifers fed in confinement for slaughterFor increased rate of weight gain, improved feed efficiency, suppression of estrus heat), for reduction of ammonia gas emissions per pound of live weight and hot carcass weight, and for the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii and for reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes in growing beef heifers fed in confinement for slaughter during the last to 91 days on feed.FOI Summary
October 23, 2024NADA 141-589Elanco US Inc.MGA and Experior (melengestrol acetate Type A medicated article and lubabegron Type A medicated article)Growing beef heifers fed in confinement for slaughterFor increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and for reduction of ammonia gas emissions per pound of live weight and hot carcass weight in growing beef heifers fed in confinement for slaughter during the last 14 to 91 days on feed.FOI Summary
October 18, 2024ANADA 200-748Huvepharma EOODPennchlor and Monovet (chlortetracycline Type A medicated article and monensin Type A medicated article)Replacement beef and dairy heifers

This supplement provides for the addition of replacement beef and dairy heifers with the following indications:

  1. For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline and for the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii in replacement beef and dairy heifers.
  2. For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline and for increased rate of weight gain in replacement beef and dairy heifers. 
FOI Summary
October 7, 2024NADA 141-581Elanco US Inc.Credelio Quattro (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets)DogsFor the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina), hookworm (adult Uncinaria stenocephala), and tapeworm (Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus) infections. Kills adult fleas and is indicated for the treatment and prevention 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 3.3 pounds or greater.FOI Summary
October 7, 2024NADA 141-554Boehringer Ingelheim Animal Health USA, Inc.NexGard PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets)DogsThis supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies eight weeks of age and older, weighing four pounds of body weight or greater, for one month. This supplement also provides for the addition of label language regarding the results of a second flea field study and improvement of erythema, alopecia, papules, scales, crusts, and excoriation in dogs with flea infestations and signs of Flea Allergy Dermatitis following treatment with afoxolaner alone, as a direct result of eliminating fleas.FOI Summary
September 23, 2024ANADA 200-776Pharmgate Inc.MGA and Bovatec and Deracin (melengestrol acetate Type A medicated article) and (lasalocid Type A medicated article) and (chlortetracycline Type A medicated article)Growing beef heifers fed in confinement for slaughter and replacement beef and
dairy heifers
  1. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), for control of coccidiosis caused by Eimeria bovis and E. zuernii, and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline in growing beef heifers fed in confinement for slaughter up to 800 pounds.
  2. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), for control of coccidiosis caused by Eimeria bovis and E. zuernii, and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in growing beef heifers fed in confinement for slaughter up to 800 pounds.
  3. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), control of coccidiosis caused by Eimeria bovis and E. zuernii, and for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in growing beef heifers fed in confinement for slaughter under 700 pounds.
  4. For suppression of estrus (heat), increased rate of weight gain, and for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in replacement beef heifers on pasture over 700 pounds.
  5. For suppression of estrus (heat), increased rate of weight gain, and for treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in replacement dairy heifers on pasture less than 20 months of age and replacement beef heifers on pasture.
  6. For suppression of estrus (heat), increased rate of weight gain, and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline in replacement beef heifers on pasture.
  7. For suppression of estrus (heat), increased rate of weight gain, and for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in replacement beef heifers on pasture under 700 pounds.
  8. For suppression of estrus (heat), control of coccidiosis caused by Eimeria bovis and E. zuernii, and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline in replacement beef heifers up to 800 pounds.
  9. For suppression of estrus (heat), control of coccidiosis caused by Eimeria bovis and E. zuernii, and for treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in replacement dairy heifers up to 800 pounds and less than 20 months of age and replacement beef heifers up to 800 pounds.
FOI Summary
September 19, 2024NADA 141-585Elanco US Inc.Zenrelia (ilunocitinib tablets)DogsFor the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.FOI Summary
September 10, 2024ANADA 200-774Cronus Pharma Specialities India Private Ltd.Tulaject 25 (tulathromycin injection)Swine, suckling calves, dairy calves, and veal calvesSwine - For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.  
Suckling Calves, Dairy Calves, and Veal Calves BRD - For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.		FOI Summary
September 5, 2024ANADA 200-773Cronus Pharma Specialities India Private Ltd.Tulaject 100 (tulathromycin injection)Beef cattle, non-lactating dairy cattle, suckling calves, dairy calves, veal calves, and swineBeef and Non-Lactating Dairy Cattle 
BRD - For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. 
IBK - For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis. 
Foot Rot - For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.
Suckling Calves, Dairy Calves, and Veal Calves BRD - For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis. 
Swine - For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.		FOI Summary
September 5, 2024ANADA 200-795Felix Pharmaceuticals Pvt. Ltd.CARPROFEN Soft Chewable TabletsDogsFor 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 26, 2024ANADA 200-783Huvepharma EOODCoxidin 90 (monensin Type A medicated article)Broiler chickens, laying hen replacement chickens, layer breeder replacement chickens, growing turkeys, and growing Bobwhite quailBroiler and Laying Hen Replacement Chicken and Layer Breeder Replacement Chicken: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. 
Turkeys: For the prevention of coccidiosis in turkeys caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis. 
Quail: For the prevention of coccidiosis in growing Bobwhite quail caused by Eimeria dispersa and E. lettyae.		FOI Summary
August 15, 2024ANADA 200-770Pharmgate Inc.MGA and Deracin (melengestrol acetate Type A medicated article and chlortetracycline Type A medicated article)Growing beef heifers fed in confinement for slaughter and replacement beef and dairy heifers
  1. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in growing beef heifers fed in confinement for slaughter.
  2. For suppression of estrus (heat), and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in replacement dairy heifers less than 20 months of age and replacement beef heifers.
  3. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and the reduction of the incidence of liver abscesses in growing beef heifers fed in confinement for slaughter over 400 lbs.
  4. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline in growing beef heifers fed in confinement for slaughter.
  5. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in growing beef heifers fed in confinement for slaughter.
  6. For suppression of estrus (heat), and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in replacement dairy heifers less than 20 months of age and replacement beef heifers.
  7. For suppression of estrus (heat), and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline in replacement dairy heifers less than 20 months of age and replacement beef heifers.
  8. For suppression of estrus (heat), and control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in replacement beef heifers over 700 pounds.
  9. For suppression of estrus (heat) and control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in replacement beef heifers under 700 pounds.
FOI Summary
July 8, 2024ANADA 200-771Norbrook Laboratories Ltd.Felanorm (methimazole)CatsFor the treatment of hyperthyroidism in cats.FOI Summary
July 2, 2024ANADA 200-788Bimeda Animal Health Ltd.MoxiSolv Injection (moxidectin)Beef and nonlactating dairy cattleFor the treatment and control of internal and external parasites of cattle.FOI Summary

 

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