Recent Animal Drug Approvals
Drug Approval Information
Approved Animal Drug Products (Green Book Online)
Animal Drugs@FDA
Freedom of Information (FOI) Summaries for 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 |
---|---|---|---|---|---|---|
June 16, 2022 | NADA 141-556 | Boehringer Ingelheim Animal Health USA, Inc. | Vetmedin®-CA1 | Dogs | Conditionally approved for the delay of onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease (2019 ACVIM Consensus Statement). Stage B2 preclinical myxomatous mitral valve disease (MMVD) refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly. |
FOI Summary |
April 28, 2022 | NADA 141-137 | Pharmgate Inc. | Pennitracin MD 50G® | Broiler and replacement chickens | This supplement provides for the addition of a therapeutic indication, “for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler and replacement chickens.” | FOI Summary |
March 30, 2022 | NADA 141-551 | Vetcare Oy | Zenalpha® | Dogs | For use as a sedative and analgesic in dogs to facilitate clinical examination, clinical procedures and minor surgical procedures. | FOI Summary |
March 28, 2022 | ANADA 200-722 | Norbrook Laboratories, Ltd. | Firox™ | Dogs | For the control of pain and inflammation associated with osteoarthritis and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery in dogs. | FOI Summary |
March 28, 2022 | ANADA 200-688 | Virbac AH, Inc. | Tenotryl™ | 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. 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 |
March 28, 2022 | ANADA 200-721 | Norbrook Laboratories, Ltd. | Midamox™ 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, intestinal roundworms (Toxocara cati), and hookworms (Ancylostoma tubaeforme). | FOI Summary |
March 23, 2022 | ANADA 200-723 | Norbrook Laboratories, Ltd. | Tulieve® | 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 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 |
March 11, 2022 | ANADA 200-720 | Norbrook Laboratories, Ltd. | Enroflox® Chewable Tablets | Dogs and cats | For the management of diseases associated with bacteria susceptible to enrofloxacin. | FOI Summary |
February 9, 2022 | ANADA 200-715 | Intervet, Inc. | AROVYN™ | 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 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 |
February 7, 2022 | ANADA 200-665 | Elanco US Inc. | Increxxa™ 25 | Swine, suckling calves, dairy calves, and veal calves | 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 |
February 7, 2022 | ANADA 200-717 | Aurora Pharmaceutical, Inc. | TiaGard™ 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 |
February 7, 2022 | ANADA 200-718 | Aurora Pharmaceutical, Inc. | Barrier™ 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 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:
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 |