Recent Animal Drug Approvals
Drug Approval Information
Approved Animal Drug Products (Green Book Online)
Animal Drugs@FDA
Freedom of Information (FOI) Summaries for Approved New 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 |
---|---|---|---|---|---|---|
December 23, 2021 | NADA 141-521 | Zoetis, Inc. | Simparica TRIO® | Dogs | This supplement provides for the addition of the indications, for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks and for the treatment and control of L4 and immature adult Ancylostoma caninum. | FOI Summary |
December 21, 2021 | NADA 141-552 | Jaguar Animal Health | CANALEVIA™-CA1 | Dogs | Conditionally approved for the treatment of chemotherapy-induced diarrhea in dogs. | FOI Summary |
December 10, 2021 | ANADA 200-705 | Elanco US Inc. | ZoaShield™ and BMD® | Broiler chickens, replacement chickens, and growing turkeys | Broiler Chickens:
Replacement Chickens:
Growing Turkeys: For prevention and control of coccidiosis, and for increased rate of weight gain and improved feed efficiency in growing turkeys. |
FOI Summary |
November 24, 2021 | ANADA 200-714 | Aurora Pharmaceutical, Inc. | Barrier™ for cats | 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. For the treatment and control of ear mite (Otodectes cynotis) infestations and the following intestinal parasites: adult, immature adult, and fourth stage larvae in hookworms (Ancylostoma tubaeforme); and adult and fourth stage larvae in roundworms (Toxocara cati). Ferrets: For the prevention of heartworm disease in ferrets caused by Dirofilaria immitis. Kills adult fleas (Ctenophalides felis) and is indicated for the treatment of flea infestations on ferrets. |
FOI Summary |
November 22, 2021 | ANADA 200-695 | Virbac AH, Inc. | TIA™ 12.5% | Swine | For the treatment of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin and for treatment of swine pneumonia due to Actinobacillus pleuropneumoniae susceptible to tiamulin. | FOI Summary |
November 15, 2021 | ANADA 200-253 | Bimeda Animal Health Ltd. | ProstaMate® | Beef cows, lactating dairy cows, and replacement beef and dairy heifers | This supplement provides for the addition of the following indications and corresponding dosage regimens: for use with gonadorelin injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows; for use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in lactating dairy cows; for use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers. In addition, this supplement provides for labeling revisions to align the labels with those of the RLNAD. | FOI Summary |
November 15, 2021 | ANADA 200-669 | Virbac AH, Inc. | Tulissin® 100 | Beef cattle, non-lactating dairy cattle, suckling calves, dairy calves, veal calves, and swine | 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; 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. For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis. For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii. Suckling Calves, Dairy Calves, and Veal Calves: For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis. Swine: 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 |
November 12, 2021 | ANADA 200-668 | Virbac AH, Inc. | Tulissin® 25 | Suckling calves, dairy calves, veal calves, and swine | Swine: 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. Suckling Calves, Dairy Calves, and Veal Calves: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. |
FOI Summary |
November 3, 2021 | NADA 141-508 | Elanco US Inc. | Experior™ | Beef steers and heifers fed in confinement for slaughter | This supplement provides for addition of residue tolerances of 3 ppb in muscle and 20 ppb in kidney. | FOI Summary |
November 3, 2021 | ANADA 200-712 | Ceva Sante Animale | TULAVEN™ 25 | Suckling calves, dairy calves, veal calves, and swine | Swine: 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. Suckling Calves, Dairy Calves, and Veal Calves: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. |
FOI Summary |
November 1, 2021 | ANADA 200-711 | Ceva Sante Animale | TULAVEN™ 100 | Beef cattle, non-lactating dairy cattle, suckling calves, dairy calves, veal calves, and swine | 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; 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. For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis. For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii. Suckling Calves, Dairy Calves, and Veal Calves: For the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis. Swine: 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 |
October 29, 2021 | ANADA 200-628 | Sparhawk Laboratories, Inc. | ENROFLOXACIN 100 | 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 nonlactating 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 nonlactating 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. It is also indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed. |
FOI Summary |
October 29, 2021 | NADA 141-348 | Zoetis Inc. | SYNOVEX® ONE Grower | Growing beef steers and heifers fed in confinement for slaughter | This supplement provides for approval of the indication for increased rate of weight gain for up to 200 days in growing beef steers and heifers fed in confinement for slaughter. | |
October 28, 2021 | ANADA 200-588 | Sparhawk Laboratories, Inc. | FLORFENICOL INJECTION | 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 |
October 20, 2021 | ANADA 200-604 | Dechra Veterinary Products LLC | Amoxicillin and Clavulanate Potassium for Oral Suspension | Dogs and cats | 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. 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, Pasteurella multocida, and Pasteurella spp. Urinary tract infections (cystitis) due to susceptible strains of E. coli. |
FOI Summary |
October 1, 2021 | ANADA 200-691 | Virbac AH, Inc. | RAC™ 45 CATTLE | Cattle fed in confinement for slaughter | Complete Feed: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in cattle fed in confinement for slaughter during the last 28 to 42 days on feed. Top Dress Feed: For increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter during the last 28 to 42 days on feed. |
FOI Summary |
August 19, 2021 | NADA 141-063 | Intervet, Inc. | Nuflor®-S | Swine, except for nursing piglets and swine of reproductive age intended for breeding | This supplement provides for the treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella Choleraesuis, Streptococcus suis, Bordetella bronchiseptica, and Glaesserella (Haemophilus) parasuis in swine except for nursing piglets and swine of reproductive age intended for breeding. | FOI Summary |
August 18, 2021 | ANADA 200-709 | Cronus Pharma Specialities India Private Ltd. | Amoxicillin and Clavulanate Potassium for Oral Suspension | Dogs and cats | For the treatment of the following: 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. 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, Pasteurella multocida, and Pasteurella spp. Urinary tract infections (cystitis) due to susceptible strains of E. coli. |
FOI Summary |
August 16, 2021 | ANADA 200-618 | Virbac AH, Inc. | Zoletil™ for Injection | Dogs | This supplement provides for the addition of a new indication, the intravenous administration for induction of anesthesia followed by maintenance with an inhalant anesthetic in dogs. | FOI Summary |
August 2, 2021 | ANADA 200-708 | Felix Pharmaceuticals Pvt. Ltd. | Enrofloxacin | Dogs | For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin. | FOI Summary |
July 15, 2021 | NADA 141-545 | VetDC, Inc. | TANOVEA® | Dogs | For the treatment of lymphoma in dogs. | FOI Summary |
July 7, 2021 | ANADA 200-703 | Dechra Veterinary Products LLC | Carprofen Tablets | 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 |
June 28, 2021 | ANADA 200-706 | Felix Pharmaceuticals Pvt. Ltd. | CARPROFEN Chewable Tablets | 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 |
June 14. 2021 | ANADA 200-704 | Felix Pharmaceuticals Pvt. Ltd. | Deracoxib Chewable Tablets | Dogs | For the control of pain and inflammation associated with osteoarthritis, for the control of postoperative pain and inflammation associated with orthopedic surgery, and for the control of postoperative pain and inflammation associated with dental surgery. | FOI Summary |
June 14, 2021 | NADA 128-620 | Intervet, Inc. | Safe-Guard® Panacur® |
Beef and dairy cattle and goats | This supplement provides for tolerances, a tissue withdrawal period, and a milk discard time in cattle; and a tolerance and tissue withdrawal period in goats in accordance with a repartitioning of the acceptable daily intake (ADI). | FOI Summary |
June 10, 2021 | ANADA 200-701 | Chanelle Pharmaceuticals Manufacturing Ltd. | PARASEDGE™ Multi for Cats | 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 and the following intestinal parasites: adult, immature adult, and fourth stage larvae in hookworms (Ancyclostoma tubaeforme); and adult and fourth stage larvae in roundworms (Toxacara cati). | FOI Summary |
June 10, 2021 | ANADA 200-700 | Chanelle Pharmaceuticals Manufacturing Ltd. | PARASEDGE™ Multi for Dogs | Dogs | For the prevention of heartworm disease caused by Dirofilaria immitis and the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs. Kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis). For the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis. It is also indicated for the treatment and control of the following intestinal parasites: adult, immature adult, and fourth stage larvae in hookworms (Ancyclostoma caninum and Unicinaria stenocephala); and adult stage in roundworms (Toxacara canis and Toxascaris leonina) and whipworms (Trichuris vulpis). | FOI Summary |
June 1, 2021 | NADA 141-543 | Zoetis Inc. | Draxxin® KP | Cattle: beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers |
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers. | FOI Summary |