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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
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
October 20, 2023 NADA 141-564 Pharmgate Inc. Pennchlor and Rumensin (chlortetracyclinel and monensin) Replacement beef and dairy heifers This supplement provides for the addition of replacement beef and dairy heifers with the following indications:
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; and
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 13, 2023 NADA 141-336 ECO LLC AIVLOSIN (62.5% w/w tylvalosin as tylvalosin tartrate) Female swine intended for breeding (replacement gilts, gestating replacement gilts, gestating sows, lactating sows, and weaned sows) This supplement provides for the addition of female swine intended for breeding (replacement gilts, gestating replacement gilts, gestating sows, lactating sows, and weaned sows) to the classes approved for the control of porcine proliferative enteropathy and control of swine respiratory disease indications, and provides for removal of the precaution “Not for use in lactating or pregnant females or females intended for breeding” from the labeling. FOI Summary
October 11, 2023 NADA 141-572 Virbac AH, Inc. AYRADIA (metronidazole) Dogs For the treatment of Giardia duodenalis infection in dogs. FOI Summary
September 20, 2023 ANADA 200-310 Parnell Technologies Pty. Ltd. estroPLAN (cloprostenol) Lactating dairy cows This supplement provides for the addition of the indication “For use with gonadorelin to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows.” FOI Summary
September 6, 2023 NADA 141-578 Genus Lifesciences Inc. FIDOQUEL-CA1 (phenobarbital) Dogs Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs. FOI Summary

 

 

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