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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 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, 2022 NADA 141-450 Intervet, Inc. Banamine® Transdermal Cattle/Beef cattle 2 months of age and older and dairy cattle. Not for use in beef and dairy bulls intended for breeding over 1 year of age, replacement dairy heifers over 20 months of age, dry dairy cows, dairy calves, or veal calves This supplement provides for 1) the addition of a therapeutic indication “for the control of pyrexia associated with acute bovine mastitis”; 2) the addition of the lactating dairy cow target animal subclass for all approved indications; and 3) a milk discard time.

FOI Summary

FONSI

EA
December 20, 2022 NADA 141-559 Anzac Animal Health, LLC Zycosan™ Horses For the control of clinical signs associated with osteoarthritis in horses FOI Summary
December 15, 2022 ANADA 200-455 Bimeda Animal Health Ltd. BiloVet® Broiler Chickens This supplement provides for the addition of the indications and dosage and administration for the control of mortality caused by necrotic enteritis (NE) associated with Clostridium perfringens in broiler chickens. FOI Summary
December 8, 2022 NADA 141-566 INCREVET INC Bexacat™ Cats To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin FOI Summary
December 2, 2022 NADA 141-529 Pharmgate Inc. Pennitracin MD® and Maxiban™ Broiler Chickens This supplement provides for the new indication, for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens, and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima in broiler chickens. FOI Summary
December 2, 2022 ANADA 200-377 Bimeda Animal Health Ltd. LinxMed-SP® Honey bees This supplement provides for labeling changes to include the addition of a new indication for the control of American foulbrood (Paenibacillus larvae) in honey bees. FOI Summary
November 14, 2022 NADA 141-567 Ishihara Sangyo Kaisha, Ltd. PANOQUELL®-CA1 Dogs Conditionally approved for the management of clinical signs associated with acute onset of pancreatitis in dogs. FOI Summary
November 4, 2022 ANADA 200-730 Parnell Technologies Pty. Ltd. RESPIRmycin™ Beef cattle, non-lactating dairy cattle, suckling calves, dairy calves, veal calves, and swine Beef and Non-Lactating Dairy Cattle
BRD – 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.
IBK – For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.
Foot Rot – For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.
Suckling Calves, Dairy Calves, and Veal Calves BRD – 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
September 29, 2022 ANADA 200-694 Bimeda Animal Health Ltd. SpectoGard® Cattle For the treatment of bovine respiratory disease (pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. FOI Summary
September 28, 2022 ANADA 200-719 Vetoquinol USA, Inc. SIMPLERA™ Dogs For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius). FOI Summary
September 9, 2022 NADA 141-553 Zoetis Inc. VALCOR™ Cattle: beef cattle two months of age and older and in replacement dairy heifers less than 20 months of age. Not for use in beef bulls intended for breeding over 1 year of age, dairy calves, and veal calves For the treatment and control of gastrointestinal roundworms (adults and fourth stage larvae) - Ostertagia ostertagi (including inhibited larvae), O. lyrata, Haemonchus placei, Trichostrongylus axei, T. colubriformis, T. longispicularis*, Cooperia oncophora, C. pectinata*, C. punctata, C. surnabada, Bunostomum phlebotomum*, Strongyloides papillosus*, Oesophagostomum radiatum, Trichuris spp.*, and Nematodirus helvetianus*; lungworms (adults and fourth stage larvae) - Dictyocaulus viviparus; eyeworms (adults) - Thelazia spp.; grubs (parasitic stages) - Hypoderma bovis and H. lineatum; sucking lice - Haematopinus eurysternus, Linognathus vituli, and Solenopotes capillatus; mange mites - Psoroptes bovis and Sarcoptes scabiei.
*adults only		 FOI Summary
September 6, 2022 NADA 141-462 Phibro Animal Health Corp. Stafac® and Monteban™ Broiler chickens For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima in broiler chickens. FOI Summary
September 6, 2022 NADA 141-429 Phibro Animal Health Corp. Stafac® and Maxiban™ Broiler chickens For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima in broiler chickens. FOI Summary
August 11, 2022 NADA 141-565 Pharmgate Inc. Pennitracin MD® and Coban™ Broiler chickens, laying hen replacement chickens, and layer breeder
replacement chickens
  1. For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens, and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima in broiler chickens.
  2. For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens, and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima in laying hen replacement chickens and layer breeder replacement chickens.
  3. For increased rate of weight gain and improved feed efficiency, and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima in broiler chickens.
  4. For increased rate of weight gain and improved feed efficiency, and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima in laying hen replacement chickens and layer breeder replacement chickens.
 FOI Summary
August 9, 2022 NADA 141-518 Intervet, Inc. BRAVECTO® PLUS Cats This supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (Asian longhorned tick) infestations for 2 months in cats and kittens 6 months of age and older and weighing 2.6 pounds or greater. FOI Summary
August 9, 2022 NADA 141-459 Intervet, Inc. BRAVECTO® Cats This supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (Asian longhorned tick) infestations for 12 weeks in cats and kittens 6 months of age and older, and weighing 2.6 pounds or greater. FOI Summary
July 29, 2022 ANADA 200-726 Pegasus Laboratories, Inc. Firocoxib Tablets for Horses Horses For the control of pain and inflammation associated with osteoarthritis in horses. FOI Summary
July 29, 2022 ANADA 200-727 Felix Pharmaceuticals Pvt. Ltd. Meloxicam Dogs and cats Dogs: Meloxicam Injection is indicated in dogs for the control of pain and inflammation associated with osteoarthritis.
Cats: For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery.		 FOI Summary
July 28, 2022 NADA 141-564 Pharmgate Inc. Pennchlor® and Rumensin™ Beef calves 2 months of age and older, and growing beef steers and heifers fed in confinement for slaughter
  • 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 due to Eimeria bovis and Eimeria zuernii in beef calves 2 months of age and older.
  • For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in growing beef steers and heifers fed in confinement for slaughter over 700 lbs.
  • For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter over 700 lbs.
  • 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 due to Eimeria bovis and Eimeria zuernii in growing beef steers and heifers fed in confinement for slaughter.
  • For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline and for improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter.
  • For the reduction of the incidence of liver abscesses and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in growing beef steers and heifers fed in confinement for slaughter over 400 lbs.
  • For the reduction of the incidence of liver abscesses and for improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter over 400 lbs.
  • For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in growing beef steers and heifers fed in confinement for slaughter under 700 lbs.
  • For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter under 700 lbs.
  • For the control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in growing beef steers and heifers fed in confinement for slaughter.
  • For the control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline and for improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter.
 FOI Summary
July 19, 2022 ANADA 200-725 Huvepharma EOOD Experior™ and Monovet® Beef steers and heifers fed in confinement for slaughter For reduction of ammonia gas emissions per pound of live weight and hot carcass weight and improved feed efficiency in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.

For reduction of ammonia gas emissions per pound of live weight and hot carcass weight and prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.		 FOI Summary
July 19, 2022 ANADA 200-724 Huvepharma EOOD Experior™ and Monovet® and Tylovet® Beef steers and heifers fed in confinement for slaughter For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, improved feed efficiency, and reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.

For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, prevention and control of coccidiosis due to Eimeria bovis and
Eimeria zuernii, and reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.		 FOI Summary
July 18, 2022 NADA 141-348 Zoetis Inc. SYNOVEX® ONE FEEDLOT Growing beef steers and heifers fed in confinement for slaughter This supplement provides for the 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 in a reimplantation program where SYNOVEX Choice® is the first implant and a SYNOVEX® ONE FEEDLOT implant is administered 60 to 120 days later. FOI Summary

FONSI

EA
July 18, 2022 NADA 141-043 Zoetis Inc. SYNOVEX Choice® and SYNOVEX PLUS® Growing beef steers and heifers fed in confinement for slaughter This supplement provides for the approval of the following indications:

For SYNOVEX Choice®: For increased rate of weight gain for up to 200 days in growing beef steers and heifers fed in confinement for slaughter in a reimplantation program where SYNOVEX Choice® is the first implant and a SYNOVEX Choice®, SYNOVEX PLUS®, or SYNOVEX® ONE FEEDLOT implant is administered 60 to 120 days later.

For SYNOVEX PLUS®: For increased rate of weight gain for up to 200 days in growing beef steers and heifers fed in confinement for slaughter in a reimplantation program where SYNOVEX Choice® is the first implant and a SYNOVEX PLUS® implant is administered 60 to 120 days later.		 FOI Summary

FONSI

EA
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

 

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