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  1. Approved Animal Drug Products (Green Book)

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
May 23, 2024 NADA 131-675 Intervet Inc. Safe-Guard (fenbendazole) Wild quail This supplement provides for the addition of wild quail with the indication for the treatment and control of Aulonocephalus spp. in wild quail. FOI Summary
May 16, 2024 ANADA 200-781 Cronus Pharma Specialities India Private Ltd. Flunine (flunixin meglumine injection)  Horses, beef cattle, and dairy cattle (excluding dry dairy cows) Horse: For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse. 
Cattle: For the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. It is also indicated for the control of inflammation in endotoxemia.
FOI Summary
May 10, 2024 NADA 141-577 Vetoquinol USA, Inc. UpCard-CA1 (torsemide oral solution) Dogs For use with concurrent therapy with pimobendan, spironolactone, and an angiotensin converting enzyme (ACE) inhibitor for the management of pulmonary edema in dogs with congestive heart failure caused by myxomatous mitral valve disease (MMVD). FOI Summary
May 9, 2024 ANADA 200-782 Cronus Pharma Specialities India Private Ltd. EnroPro Silver Otic (enrofloxacin/silver sulfadiazine) Dogs As a treatment for canine otitis externa complicated by bacterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine. FOI Summary
May 8, 2024 ANADA 200-780 Aurora Pharmaceutical, Inc. CocciAid for Calves (amprolium) Beef and dairy calves An aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zurnii in calves. FOI Summary
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

 

 

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