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  1. Approved Animal Drug Products (Green Book)

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
January 28, 2022 ANADA 200-716 Norbrook Laboratories, Ltd. Midamox™ 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; and for the treatment and control of intestinal roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum and Uncinaria stenocephala), and whipworms (Trichuris vulpis). FOI Summary
January 25, 2022 ANADA 200-707 Huvepharma EOOD Tilmovet® AC Swine For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.
For the control of swine respiratory disease associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diagnosed.		 FOI Summary
January 20, 2022 NADA 141-547 Elanco US Inc. Zorbium™ Cats For the control of postoperative pain associated with surgical procedures in cats. FOI Summary
January 13, 2022 NADA 141-546 Zoetis Inc. Solensia™ Cats For the control of pain associated with osteoarthritis in cats. FOI Summary
January 10, 2022 NADA 131-675 Intervet, Inc. Safe-Guard® Cattle/Dairy and Beef Cattle;
Swine/Growing pigs, gilts, pregnant sows and boars; and
Turkeys/Growing Turkeys		 This supplement provides for 1) tolerances and tissue withdrawal periods in cattle, swine, and turkeys, and a milk discard time in cattle in accordance with a repartitioning of the acceptable daily intake (ADI); and 2) the addition of fourth stage larval indications for barberpole worms (Haemonchus contortus & H. placei), small stomach worms (Trichostrongylus axei), hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata & C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum) in cattle. FOI Summary
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:
  1. For prevention and control of coccidiosis and as an aid in the prevention of necrotic enteritis caused by or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
  2. For prevention and control of coccidiosis and as an aid in the control of necrotic enteritis caused by or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

Replacement Chickens:

  1. Development of active immunity to coccidiosis and as an aid in the prevention of necrotic enteritis caused by or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
  2. Development of active immunity to coccidiosis and as an aid in the control of necrotic enteritis caused by or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
  3. Development of active immunity to coccidiosis and as an aid in the prevention of necrotic enteritis caused by or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
  4. Development of active immunity to coccidiosis and as an aid in the control of necrotic enteritis caused by or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
  5. Development of active immunity to coccidiosis and as an aid in the prevention of necrotic enteritis caused by or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
  6. Development of active immunity to coccidiosis and as an aid in the control of necrotic enteritis caused by or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
  7. Development of active immunity to coccidiosis and as an aid in the prevention of necrotic enteritis caused by or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
  8. Development of active immunity to coccidiosis and as an aid in the control of necrotic enteritis caused by or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

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.

FOI Summary

FONSI

EA
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

 

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