Recent Animal Drug Approvals
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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 |
|---|---|---|---|---|---|---|
| March 24, 2025 | ANADA 200-810 | Hikma Pharmaceuticals USA, Inc. | Enrofloxacin Flavored Tablets | Dogs and cats | For the management of diseases associated with bacteria susceptible to enrofloxacin in dogs and cats. | FOI Summary |
| March 24, 2025 | ANADA 200-811 | Bimeda Animal Health Ltd. | MoxiCloprid for Cats (imidacloprid + moxidectin) | Cats and ferrets | Cats: For the prevention of heartworm disease caused by Dirofilaria immitis; kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations. It is also indicated for the treatment and control of ear mite (Otodectes cynotis) infestations, intestinal roundworms (Toxocara cati), and hookworms (Ancylostoma tubaeforme). Ferrets: For the prevention of heartworm disease in ferrets caused by Dirofilaria immitis; kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations on ferrets. | FOI Summary |
| 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 |