Recent Animal Drug Approvals
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 |
---|---|---|---|---|---|---|
April 26, 2024 | NADA 141-582 | Warburton Technology Ltd. | MULTIMIN 90 (zinc, copper, manganese, and selenium) | Cattle. Not for use in pregnant cows and heifers during their first trimester because reproductive safety testing has not been done in these animals. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety has not been established. | To provide a supplemental source of zinc, copper, manganese, and selenium in cattle. Not for use in pregnant cows and heifers during their first trimester because reproductive safety testing has not been done in these animals. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety has not been established. | FOI Summary |
April 25, 2024 | ANADA 200-728 | Cronus Pharma Specialities India Private Ltd. | Pimomedin (pimobendan) | Dogs | For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis. | FOI Summary |
April 10, 2024 | ANADA 200-777 | Felix Pharmaceuticals Pvt. Ltd. | Carprofen | 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 |
April 9, 2024 | NADA 141-550 | Elanco US Inc. | Pradalex (pradofloxacin) | Cattle: For use in cattle intended for slaughter (beef calves 2 months of age and older, growing beef steers, growing beef heifers, and beef bulls intended for slaughter), and in cattle intended for breeding less than 1 year of age (replacement beef and dairy heifers less than 1 year of age and beef and dairy bulls less than 1 year of age). Not for use in cattle intended for breeding 1 year of age and older (replacement beef and dairy heifers 1 year of age and older, beef and dairy bulls 1 year of age and older, and beef and dairy cows), beef calves less than 2 months of age, dairy calves, and veal calves. Swine: For use in weaned swine intended for slaughter (nursery, growing, and finishing swine, boars intended for slaughter, barrows, gilts intended for slaughter, and sows intended for slaughter). Not for use in swine intended for breeding (boars intended for breeding, replacement gilts, and sows intended for breeding) and in nursing piglets. |
Cattle: For the treatment of BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in cattle intended for slaughter (beef calves 2 months of age and older, growing beef steers, growing beef heifers, and beef bulls intended for slaughter), and in cattle intended for breeding less than 1 year of age (replacement beef and dairy heifers less than 1 year of age and beef and dairy bulls less than 1 year of age). Not for use in cattle intended for breeding 1 year of age and older (replacement beef and dairy heifers 1 year of age and older, beef and dairy bulls 1 year of age and older, and beef and dairy cows), beef calves less than 2 months of age, dairy calves, and veal calves. Swine: For the treatment of SRD associated with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae in weaned swine intended for slaughter (nursery, growing, and finishing swine, boars intended for slaughter, barrows, gilts intended for slaughter, and sows intended for slaughter). Not for use in swine intended for breeding (boars intended for breeding, replacement gilts, and sows intended for breeding) and in nursing piglets. |
FOI Summary |
April 5, 2024 | NADA 141-043 | Zoetis Inc. | SYNOVEX Choice and SYNOVEX PRIMER (trenbolone acetate and estradiol benzoate) | Growing beef steers and heifers in a dry lot | This supplement provides for the approval of a new indication to SYNOVEX Choice for increased rate of weight gain in growing beef steers and heifers in a dry lot; and, adds the approval of SYNOVEX PRIMER for increased rate of weight gain in growing beef steers and heifers in a dry lot. | FOI Summary FONSI EA |
March 15, 2024 | NADA 141-579 | Dechra, Ltd. | DuOtic (terbinafine and betamethasone acetate) | Dogs | For the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis). | FOI Summary |
March 1, 2024 | ANADA 200-772 | Parnell Technologies Pty. Ltd. | CONTRASED (atipamezole hydrochloride) | Dogs | For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs. | FOI Summary |
February 22, 2024 | ANADA 200-749 | Ceva Sante Animale | Kesium (amoxicillin and clavulanate potassium) | Dogs and cats | Kesium Chewable Tablets are indicated in the treatment of: Dogs: Skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: β-lactamase-producing Staphylococcus aureus, non-β-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and E. coli. Periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria. Kesium has been shown to be clinically effective for treating cases of canine periodontal disease. Cats: Skin and soft tissue infections such as wounds, abscesses, and cellulitis/dermatitis due to susceptible strains of the following organisms: β-lactamase-producing Staphylococcus aureus, non-β-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella spp. Urinary tract infections (cystitis) due to susceptible strains of E. coli. |
FOI Summary |
February 13, 2024 | NADA 141-575 | Boehringer Ingelheim Animal Health USA, Inc. | Vetmedin Solution (pimobendan) | Dogs | For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis. | FOI Summary |
January 30, 2024 | ANADA 200-769 | ZyVet Animal Health, Inc. | Selamectin | Dogs and cats | Selamectin is recommended for use in dogs six weeks of age or older and cats eight weeks of age and older for the following parasites and indications: Dogs: Kills adult fleas and prevents flea eggs from hatching for one month and is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and the treatment and control of ear mite (Otodectes cynotis) infestations. It is also indicated for the treatment and control of sarcoptic mange (Sarcoptes scabiei) and for the control of tick infestations due to Dermacentor variabilis. Cats: Kills adult fleas and prevents flea eggs from hatching for one month and is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and the treatment and control of ear mite (Otodectes cynotis) infestations. It is also indicated for the treatment and control of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections in cats. |
FOI Summary |
January 12, 2024 | ANADA 200-768 | Huvepharma EOOD | Ravantage 9 and Ravantage 45 (ractopamine hydrochloride) | Finishing swine | For increased rate of weight gain, improved feed efficiency and increased carcass leanness in finishing swine, weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter. | FOI Summary |
January 12, 2024 | ANADA 200-767 | Felix Pharmaceuticals Pvt. Ltd. | Carprofen Tablets (carprofen) | 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 |
January 11, 2024 | ANADA 200-766 | Aurora Pharmaceutical, Inc. | EquiCoxib (firocoxib) | Horses | For the control of pain and inflammation associated with osteoarthritis in horses. | FOI Summary |
December 22, 2023 | ANADA 200-765 | Cronus Pharma Specialities India Private Ltd. | EnroPro 100 (enrofloxacin) | Beef cattle, non-lactating dairy cattle, and swine | Cattle – Single-Dose Therapy: 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 BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis. Cattle – Multiple-Day Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle. Swine: For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. For the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed. |
FOI Summary |
December 22, 2023 | ANADA 200-764 | Cronus Pharma Specialities India Private Ltd. | EnroPro 22.7 (enrofloxacin) | Dogs | For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin. | FOI Summary |
December 22, 2023 | ANADA 200-762 | Cronus Pharma Specialities India Private Ltd. | Carofenvet (carprofen) | 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 |
December 21, 2023 | ANADA 200-760 | Cronus Pharma Specialities India Private Ltd. | Florfeniject (florfenicol) | Beef and non-lactating dairy cattle | For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and for the treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus. Also, it is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. | FOI Summary |
December 14, 2023 | NADA 141-502 | Zoetis Inc. | revolution PLUS (selamectin and sarolaner) | Cats | This supplement provides for the addition of the indication for the treatment and control of tick infestations with Amblyomma americanum (lone star tick) for one month in cats and kittens 8 weeks and older, and weighing 2.8 pounds or greater. | FOI Summary |
November 17, 2023 | NADA 141-580 | Orion Corp. | Bonqat (pregabalin) | Cats | For alleviation of acute anxiety and fear associated with transportation and veterinary visits in cats. | FOI Summary |
November 8, 2023 | ANADA 200-758 | Felix Pharmaceuticals Pvt. Ltd. | Enrofloxacin | Beef cattle, non-lactating dairy cattle, and swine | Cattle – Single-Dose Therapy: 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 BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis. Cattle – Multiple-Day Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle. Swine: For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae; and for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed. |
FOI Summary |