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 |
|---|---|---|---|---|---|---|
| October 24, 2025 | 141-494 | Elanco US Inc. | Credelio™ (lotilaner) | Dogs | This supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (longhorned tick) tick infestations for one month in dogs and puppies 8 weeks of age and older, weighing 4.4 pounds or greater, and for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. | FOI Summary |
| October 21, 2025 | 141-574 | Pharmgate Inc. | Pennitracin MD 50G® and Monteban™ (bacitracin Type A medicated article) and (narasin Type A medicated article) | Broiler chickens | 1) For increased rate of weight gain and improved feed efficiency, and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima in broiler chickens. 2) For 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 21, 2025 | 200-825 | Felix Pharmaceuticals Pvt. Ltd. | Clomipramine Hydrochloride Tablets | Dogs | For use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age. | FOI Summary |
| October 20, 2025 | 141-581 | Elanco US Inc. | Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) | Dogs | This supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (longhorned tick) tick infestations for one month in dogs and puppies 8 weeks of age and older, weighing 3.3 pounds or greater, and for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. | FOI Summary |
| September 30, 2025 | 141-616 | Zoetis Inc. | DECTOMAX®-CA1 (doramectin injection) | Cattle | For prevention and treatment of infestations caused by larvae of Cochliomyia hominivorax (myiasis), and prevention of reinfestation for 21 days in cattle. | FOI Summary |
| September 19, 2025 | 200-824 | Felix Pharmaceuticals Pvt. Ltd. | Dexmedetomidine Hydrochloride | Dogs and cats | For use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia in dogs and cats. | FOI Summary |
| September 19, 2025 | 141-585 | Elanco US Inc. | Zenrelia™ (ilunocitinib) | Dogs | This supplement provides for revisions to the boxed warning and Animal Safety Warnings. | FOI Summary |
August 28, 2025 | 200-821 | Parnell Technologies Pty. Ltd. | Isoflurane | Horses and Dogs | For induction and maintenance of general anesthesia in horses and dogs.
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August 28, 2025 | 200-819 | Bimeda Animal Health Ltd. | GAMROZYNE™ (gamithromycin) | Beef and non-lactating dairy cattle | For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with Mannheimia haemolytica and Pasteurella multocida. | |
August 14, 2025 | 200-794 | Cronus Pharma Specialities India Private Ltd. | Meloxisol™ (meloxicam oral suspension) | Dogs | For the control of pain and inflammation associated with osteoarthritis in dogs. |
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August 5, 2025 | 200-818 | Bimeda Animal Health Ltd. | MoxiCloprid™ for Dogs (imidacloprid + moxidectin) | Dogs | For the prevention of heartworm disease caused by Dirofilaria immitis; and the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs; and the treatment and control of intestinal roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum and Uncinaria stenocephala), and whipworms (Trichuris vulpis); kills adult fleas and treats flea infestations (Ctenocephalides felis); treats and controls sarcoptic mange caused by Sarcoptes scabiei var. canis. | |
| July 21, 2025 | 200-817 | Felix Pharmaceuticals Pvt. Ltd. | Meloxicam Oral Suspension | Dogs | For the control of pain and inflammation associated with osteoarthritis in dogs. | FOI Summary |
| July 18, 2025 | 200-759 | ZyVet Animal Health, Inc. | Furosemide Tablets | Dogs and Cats | For treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema. | FOI Summary |
| July 17, 2025 | 141-607 | Intervet, Inc. | Exzolt™ (fluralaner oral solution) | Chickens, laying hens and replacement chickens | For the treatment and control of northern fowl mites (Ornithonyssus sylviarum). | FOI Summary |
| July 11, 2025 | 200-816 | Cronus Pharma Specialities India Private Ltd. | Meloxisol™ (meloxicam oral suspension) | Dogs | For the control of pain and inflammation associated with osteoarthritis in dogs. | FOI Summary |
| July 10, 2025 | 141-599 | Intervet, Inc. | BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension) | Dogs | Kills adult fleas and for the treatment and prevention of flea infestations (Ctenocephalides felis); for the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)] for 12 months in dogs and puppies 6 months of age and older; and for the treatment and control of Amblyomma Americanum (lone star tick) infestations for 8 months in dogs and puppies 6 months of age and older. | FOI Summary |
| July 8, 2025 | 200-815 | Felix Pharmaceuticals Pvt. Ltd. | Cefpodoxime Proxetil Tablets | Dogs | For the treatment of skin infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, Streptococcus canis (group G, β hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis. | FOI Summary |
| July 8, 2025 | 200-808 | Huvepharma EOOD | MGA® and Experior™ and Monovet® and Tylovet® (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 14 to 91 days on feed. | FOI Summary |
| July 8, 2025 | 200-807 | Huvepharma EOOD | MGA® and Experior™ and Monovet® (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 |
| June 27, 2025 | 200-814 | Felix Pharmaceuticals Pvt. Ltd. | Methimazole Coated Tablets | Cats | For the treatment of hyperthyroidism in cats. |
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| June 27, 2025 | 200-813 | Felix Pharmaceuticals Pvt. Ltd. | Clindamycin Hydrochloride Tablets | Dogs | For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens, dental infections due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens, and osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens. |
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| June 24, 2025 | 200-812 | Qilu Animal Health Products Co., Ltd. | Cefovecin Sodium for Injection | Dogs and Cats | Dogs: For the treatment of skin infections (secondary superficial pyoderma, abscesses, and wounds) in dogs caused by susceptible strains of Staphylococcus intermedius and Streptococcus canis (Group G). Cats: For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida. |
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| May 21, 2025 | 141-581 | Elanco US Inc. | Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) | Dogs | This supplement provides for the addition of the indication for the treatment and control of hookworm (fourth stage larvae, immature adult, and adult Ancylostoma caninum) infections in dogs and puppies 8 weeks of age and older, and weighing 3.3 pounds or greater. |
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April 29, 2025
| 141-600 | Intervet, Inc. | Mometamax Single™ (gentamicin, posaconazole, and mometasone furoate otic suspension) | Dogs | For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa) in dogs. |
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April 29, 2025
| 141-609 | Genus plc | DELETION OF EXON 7 OF CD163 GENE IN DOMESTIC PIGS | Domestic Pigs | Deletion of exon 7 of the CD163 gene in domestic pigs (Sus scrofa domesticus) is intended to confer resistance to porcine reproductive and respiratory syndrome virus (PRRSV) in homozygous pigs. Pigs carrying one or two copies of CD163∆E7, and their offspring, are intended for breeding or to be used sources as of food. |
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| April 24, 2025 | 200-802 | Huvepharma EOOD | Pennitracin MD® and Coxidin® (bacitracin Type A medicated article and monensin Type A medicated article) | Growing turkeys | For increased rate of weight gain and improved feed efficiency, and for the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis in growing turkeys. |
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April 24, 2025
| 200-801 | Huvepharma EOOD | Inteprity™ and Coxidin® (avilamycin Type A medicated article and monensin Type A medicated article) | Broiler chickens | For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens; and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, in broiler chickens. |
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April 24, 2025
| 200-800 | Huvepharma EOOD | Coxidin® and Flavomycin® (monensin Type A medicated article and bambermycins Type A medicated article) | Growing turkeys | 1. For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis; and for improved feed efficiency in growing turkeys. 2. For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis; and for increased rate of weight gain and improved feed efficiency in growing turkeys. |
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April 24, 2025
| 200-799 | Huvepharma EOOD | Coxidin® and BMD® (monensin Type A medicated article and bacitracin methylenedisalicylate Type A medicated article) | Growing turkeys | 1. For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis; and for increased rate of weight gain and improved feed efficiency in growing turkeys. 2. For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis; and as an aid in the control for transmissible enteritis in growing turkeys complicated by organisms susceptible to bacitracin methylenedisalicylate. |
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April 24, 2025
| 200-798 | Huvepharma EOOD | Flavomycin® and Coxidin® (bambermycins Type A medicated article and monensin Type A medicated article) | Broiler chickens | As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency. | FOI Summary |
April 24, 2025
| 200-797 | Huvepharma EOOD | Coxidin® and BMD® (monensin Type A medicated article and bacitracin methylenedisalicylate Type A medicated article) | Broiler chickens | As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for increase in rate of weight gain and improved feed efficiency in broiler chickens. |
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April 23, 2025
| 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 prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. |
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| April 10, 2025 | 141-598 | Dechra, Ltd. | Otiserene® (marbofloxacin, terbinafine, and dexamethasone otic suspension) | Dog | For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius) in dogs. |
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April 8, 2025
| 141-587 | Phibro Animal Health Corp. | Optaflexx™ and Rumensin™ and V-Max® (ractopamine hydrochloride Type A medicated article and monensin Type A medicated article and virginiamycin) | Cattle/growing beef steers and heifers fed in confinement for slaughter | 1. For increased rate of weight gain, improved feed efficiency, the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii, and reduction of incidence of liver abscesses in growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed. 2. For increased rate of weight gain, improved feed efficiency, increased carcass leanness, the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii, and reduction of incidence of liver abscesses in growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed. 3. For increased rate of weight gain and improved feed efficiency, the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii, and reduction of incidence of liver abscesses in growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed when ractopamine hydrochloride is used as a top dress with rations containing monensin and virginiamycin. |
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| April 8, 2025 | 141-521 | Zoetis Inc. | Simparica TRIO® (sarolaner, moxidectin, and pyrantel chewable tablets) | Dogs | 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 dog for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. |
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| April 7, 2025 | 141-588 | Phibro Animal Health Corp. | Rumensin™ and V-Max® (monensin Type A medicated article and virginiamycin) | Cattle/growing beef steers and heifers fed in confinement for slaughter | 1. For the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii, and reduction of incidence of liver abscesses in growing beef steers and heifers fed in confinement for slaughter. 2. For improved feed efficiency and reduction of incidence of liver abscesses in growing beef steers and heifers fed in confinement for slaughter. |
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| April 7, 2025 | 141-586 | Phibro Animal Health Corp. | Experior™ and Rumensin™ and V-Max® (lubabegron Type A medicated article and monensin Type A medicated article and virginiamycin) | Cattle/growing beef steers and heifers fed in confinement for slaughter | 1. For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii, and reduction of incidence of liver abscesses in growing beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed. 2. For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, improved feed efficiency, and reduction of incidence of liver abscesses in growing beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed. |
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| April 3, 2025 | 200-791 | Cronus Pharma Specialities India Private Ltd. | Flunine-S™ (flunixin meglumine injection) | Swine | For the control of pyrexia associated with swine respiratory disease. |
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| March 14, 2025 | NADA 141-604 | TriviumVet | felycin-CA1 (sirolimus delayed-release tablets) | Cats | For the management of ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM). Subclinical HCM refers to cats with left ventricular (LV) hypertrophy (LV wall thickness of ≥6 mm at end diastole by 2D or M-mode assessment) in the absence of systemic hypertension, other causes of compensatory myocardial hypertrophy, current or historic symptoms of congestive heart failure, arterial thromboembolism, and severe LV outflow tract obstruction. | FOI Summary |
| February 25, 2025 | ANADA 200-742 | Hikma Pharmaceuticals USA, Inc. | Tulathromycin Injection | Beef cattle, non-lactating dairy cattle, suckling calves, dairy calves, veal calves, and swine | Beef and Non-Lactating Dairy Cattle BRD – Tulathromycin Injection is indicated 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 – Tulathromycin Injection is indicated for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis. Foot Rot – Tulathromycin Injection is indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii. Suckling Calves, Dairy Calves, and Veal Calves BRD – Tulathromycin Injection is indicated for the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis. Swine – Tulathromycin Injection is indicated 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 |
| January 13, 2025 | ANADA 200-626 | Bimeda Animal Health Ltd. | Eprimectin Pour-On (eprinomectin) | Beef and dairy cattle, including lactating dairy cattle | For 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 |
| December 19, 2024 | NADA 141-043 | Zoetis 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, 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:
| 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 |