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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

Date Application Number Sponsor Product Name Species Indications for Use/Effect of the Supplement Public Documents
November 25, 2024 NADA 141-532 Intervet, Inc. BRAVECTO 1-MONTH (fluralaner) Dogs This 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, 2024 NADA 141-452 Zoetis Inc. SIMPARICA (sarolaner) Dogs This 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, 2024 ANADA 200-636 Bimeda Animal Health Ltd. DORACIDE (doramectin topical solution) Cattle For 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, 2024 ANADA 200-805 Virbac 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, 2024 ANADA 200-793 Parnell Technologies Pty. Ltd. PropofolVet Multidose (propofol injectable emulsion) Dogs For 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, 2024 ANADA 200-803 Phibro 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, 2024 NADA 141-502 Zoetis Inc. revolution PLUS (selamectin and sarolaner topical solution) Cats This 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, 2024 NADA 141-521 Zoetis Inc. SimparicaTRIO (sarolaner, moxidectin, and pyrantel chewable tablets) Dogs This 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, 2024 NADA 141-590 Elanco 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 slaughter For 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, 2024 NADA 141-591 Elanco 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 slaughter For 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, 2024 NADA 141-589 Elanco US Inc. MGA and Experior (melengestrol acetate Type A medicated article and lubabegron Type A medicated article) Growing beef heifers fed in confinement for slaughter For 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, 2024 ANADA 200-748 Huvepharma EOOD Pennchlor 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, 2024 NADA 141-581 Elanco US Inc. Credelio Quattro (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) Dogs For 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, 2024 NADA 141-554 Boehringer Ingelheim Animal Health USA, Inc. NexGard PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets) Dogs This 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, 2024 ANADA 200-776 Pharmgate 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, 2024 NADA 141-585 Elanco US Inc. Zenrelia (ilunocitinib tablets) Dogs For 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, 2024 ANADA 200-774 Cronus Pharma Specialities India Private Ltd. Tulaject 25 (tulathromycin injection) Swine, suckling calves, dairy calves, and veal calves 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.  
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, 2024 ANADA 200-773 Cronus Pharma Specialities India Private Ltd. Tulaject 100 (tulathromycin injection) Beef cattle, non-lactating dairy cattle, suckling calves, dairy calves, veal calves, and swine Beef 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, 2024 ANADA 200-795 Felix Pharmaceuticals Pvt. Ltd. CARPROFEN Soft Chewable Tablets Dogs For 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, 2024 ANADA 200-783 Huvepharma EOOD Coxidin 90 (monensin Type A medicated article) Broiler chickens, laying hen replacement chickens, layer breeder replacement chickens, growing turkeys, and growing Bobwhite quail Broiler 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, 2024 ANADA 200-770 Pharmgate 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, 2024 ANADA 200-771 Norbrook Laboratories Ltd. Felanorm (methimazole) Cats For the treatment of hyperthyroidism in cats. FOI Summary
July 2, 2024 ANADA 200-788 Bimeda Animal Health Ltd. MoxiSolv Injection (moxidectin) Beef and nonlactating dairy cattle For the treatment and control of internal and external parasites of cattle. FOI Summary
June 20, 2024 ANADA 200-784 ZyVet Animal Health, Inc. Trimeprazine with Prednisolone Dogs Antipruritic: Trimeprazine with Prednisolone is recommended for the relief of itching regardless of cause. Its usefulness has been demonstrated for the relief of itching and the reduction of inflammation commonly associated with most skin disorders of dogs such as the eczema caused by internal disorders, otitis, and dermatitis (allergic, parasitic, pustular, and nonspecific). It often relieves pruritis which does not respond to other therapy.
Antitussive: Trimeprazine with Prednisolone has been found to be effective therapy and adjunctive therapy in various cough conditions of dogs. Therefore, in addition to its antipruritic action, Trimeprazine with Prednisolone is recommended for the treatment of “kennel cough” or tracheobronchitis, bronchitis including all allergic bronchitis, and infections and coughs of nonspecific origin. (Coughs due to cardiac insufficiency would not be expected to respond to Trimeprazine with Prednisolone therapy).		 FOI Summary
June 17, 2024 ANADA 200-785 Felix Pharmaceuticals Pvt. Ltd. Maropitant Citrate Tablets  Dogs For the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs. FOI Summary
June 11, 2024 ANADA 200-787 ZyVet Animal Health, Inc. Phenylpropanolamine Hydrochloride Dogs For the control of urinary incontinence due to urethral sphincter hypotonus in dogs. FOI Summary
June 4, 2024 NADA 138-255 Sparhawk Laboratories, Inc. IRON DEXTRAN 20% INJECTION Swine, nursing piglets This supplement provides for a new strength (200 mg/mL) and dose (200 mg/piglet) of the injectable solution. FOI Summary

 

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