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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
April 26, 2021 NADA 139-189 Intervet, Inc. Safe-Guard® Beef cattle This supplement provides for 1) a tolerance and tissue withdrawal periods in accordance with a repartitioning of the ADI; and 2) the addition of fourth stage larval indications for barberpole worms (Haemonchus contortus and 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). FOI Summary
April 23, 2021 ANADA 200-702 Cronus Pharma Specialities India Private Ltd. Amoxicillin and Clavulanate Potassium Tablets 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, and Pasteurella spp. Urinary tract infections (cystitis) due to susceptible strains of E. coli.		 FOI Summary
April 12, 2021 NADA 141-528 Elanco US Inc. Credelio™ CAT Cats This supplement provides for the addition of the indication for the treatment and control of Ixodes scapularis (black-legged tick) infestations for one month in cats and kittens 6 months of age and older, and weighing 2.0 pounds or greater. FOI Summary
April 5, 2021 ANADA 200-697 Accord Healthcare, Inc. Enrofloxacin Dogs For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin. FOI Summary
March 24, 2021 NADA 132-872 Intervet, Inc. Safe-Guard® Cattle/Beef and Dairy Cattle This supplement provides for 1) tolerances, a tissue withdrawal period, and a milk discard time in accordance with a repartitioning of the ADI; and 2) the addition of fourth stage larval indications for barberpole worms (Haemonchus contortus and H. placei), small stomach worms (Trichostrongylus axei), hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctate & C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum). FOI Summary
March 22, 2021 ANADA 200-625 Bimeda Animal Health Ltd. KetoMed™ Horses For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. FOI Summary
March 19, 2021 NADA 141-531 Zoetis Inc. MGA® and Bovatec® and Aureomycin® Growing beef heifers fed in confinement for slaughter and replacement beef and
dairy heifers
  1. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), for control of coccidiosis caused by Eimeria bovis and E. zuernii, and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline in growing beef heifers fed in confinement for slaughter up to 800 pounds.
  2. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), for control of coccidiosis caused by Eimeria bovis and E. zuernii, and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in growing beef heifers fed in confinement for slaughter up to 800 pounds.
  3. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), control of coccidiosis caused by Eimeria bovis and E. zuernii, and for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in growing beef heifers fed in confinement for slaughter under 700 pounds.
  4. For suppression of estrus (heat), increased rate of weight gain, and for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in replacement beef heifers on pasture over 700 pounds.
  5. For suppression of estrus (heat), increased rate of weight gain, and for treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in replacement dairy heifers on pasture less than 20 months of age and replacement beef heifers on pasture.
  6. For suppression of estrus (heat), increased rate of weight gain, and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline in replacement beef heifers on pasture.
  7. For suppression of estrus (heat), increased rate of weight gain, and for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in replacement beef heifers on pasture under 700 pounds.
  8. For suppression of estrus (heat), control of coccidiosis caused by Eimeria bovis and E. zuernii, and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline in replacement beef heifers up to 800 pounds.
  9. For suppression of estrus (heat), control of coccidiosis caused by Eimeria bovis and E. zuernii, and for treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in replacement dairy heifers up to 800 pounds and less than 20 months of age and replacement beef heifers up to 800 pounds.
 FOI Summary
March 15, 2021 NADA 141-530 Zoetis Inc. MGA® and Aureomycin® Growing beef heifers fed in confinement for slaughter and replacement beef and
dairy heifers
  1. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in growing beef heifers fed in confinement for slaughter.
  2. For suppression of estrus (heat), and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in replacement dairy heifers less than 20 months of age and replacement beef heifers.
  3. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and the reduction of the incidence of liver abscesses in growing beef heifers fed in confinement for slaughter over 400 lbs.
  4. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline in growing beef heifers fed in confinement for slaughter.
  5. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in growing beef heifers fed in confinement for slaughter.
  6. For suppression of estrus (heat), and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in replacement dairy heifers less than 20 months of age and replacement beef heifers.
  7. For suppression of estrus (heat), and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline in replacement dairy heifers less than 20 months of age and replacement beef heifers.
  8. For suppression of estrus (heat), and control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in replacement beef heifers over 700 pounds.
  9. For suppression of estrus (heat) and control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in replacement beef heifers under 700 pounds.
 FOI Summary
March 11, 2021 ANADA 200-699 Akorn Operating Company LLC (dba Akorn Animal Health Inc.) Dexmedetomidine Hydrochloride Injection Dogs and cats For use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia in dogs and cats. FOI Summary
February 26, 2021 NADA 141-540 Pharmgate, Inc. Pennitracin MD® and Coban™ Growing turkeys For increased rate of weight gain and improved feed efficiency, and for the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis in growing turkeys. FOI Summary
February 18, 2021 ANADA 200-657 Bimeda Animal Health Ltd. MACROSYN™ 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
February 18, 2021 ANADA 200-666 Elanco US Inc. Increxxa™ 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
February 16, 2021 ANADA 200-506 Chanelle Pharmaceuticals Manufacturing Ltd. Animec™ Plus® Cattle For the treatment and control of internal parasites, including adult liver flukes, and external parasites. FOI Summary
February 8, 2021 ANADA 200-466 Sparhawk Laboratories, Inc. SparMectin Plus Clorsulon Cattle This supplement provides for a decrease in the residue withdrawal period for cattle from 49 days to 21 days prior to slaughter. FOI Summary
February 1, 2021 ANADA 200-683 Huvepharma EOOD CycleGuard® and Monovet® Heifers fed in confinement for slaughter For Increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in heifers fed in confinement for slaughter. FOI Summary
February 1, 2021 ANADA 200-684 Huvepharma EOOD Optigrid® and Monovet® and CycleGuard® Heifers fed in confinement for slaughter For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and for suppression of estrus (heat) in heifers fed in confinement for slaughter during the last 28 to 42 days on feed. FOI Summary
February 1, 2021 ANADA 200-685 Huvepharma EOOD CycleGuard® and Monovet® and Tylovet® Heifers fed in confinement for slaughter For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii, reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes in heifers fed in confinement for slaughter. FOI Summary
February 1, 2021 ANADA 200-686 Huvepharma EOOD Optigrid® and Monovet® and Tylovet® and CycleGuard® Heifers fed in confinement for slaughter For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes, and suppression of estrus (heat) in heifers fed in confinement for slaughter for the last 28 to 42 days on feed. FOI Summary
January 15, 2021 NADA 141-539 Neogen Corp. ThyroKare™ Dogs For replacement therapy for diminished thyroid function in dogs. FOI Summary
January 14, 2021 NADA 141-544 Pegasus Laboratories, Inc. KBroVet®-CA1 Dogs Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs. FOI Summary
January 12, 2021 ANADA 200-676 Huvepharma EOOD Optigrid® and Monovet® and Tylovet® Cattle fed in confinement for slaughter 1) For increased rate of weight gain, improved feed efficiency, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed.
2) For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed.
3) For increased rate of weight gain, improved feed efficiency, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed.		 FOI Summary
January 12, 2021 ANADA 200-677 Huvepharma EOOD Optigrid® and Monovet® and MGA® Heifers fed in confinement for slaughter For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and suppression of estrus (heat) in heifers fed in confinement for slaughter during the last 28 to 42 days on feed. FOI Summary
January 12, 2021 ANADA 200-678 Huvepharma EOOD Optigrid® and Monovet® and Tylovet® and MGA® Heifers fed in confinement for slaughter For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and suppression
of estrus (heat) in heifers fed in confinement for slaughter for the last 28 to 42 days on feed.		 FOI Summary
January 12, 2021 ANADA 200-675 Huvepharma EOOD Optigrid® and Monovet® Cattle fed in confinement for slaughter 1) For increased rate of weight gain, improved feed efficiency and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
2) For increased rate of weight gain, improved feed efficiency, increased carcass leanness and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
3) For increased rate of weight gain and improved feed efficiency; and for prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.		 FOI Summary
January 11, 2021 NADA 141-526 Anivive Lifesciences, Inc. LAVERDIA™-CA1 Dogs Conditionally approved for the treatment of lymphoma in dogs. FOI Summary
January 7, 2021 NADA 141-336 ECO LLC Aivlosin® Swine intended for slaughter This supplement provides for the addition of Mycoplasma hyopneumoniae to the list of pathogens in the indication for control of swine respiratory disease. FOI Summary
December 16, 2020 ANADA 200-696 Bimeda Animal Health Ltd. SelaSpot™ Dogs and cats SelaSpot™ 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
December 14, 2020 NADA 141-542 Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corporation pPL657 rDNA CONSTRUCT IN DOMESTIC PIGS Domestic Pigs Undetectable endogenous galactose-alpha-1,3-galactose sugar residues on
biological derivatives of the homozygous GalSafe® lineage that are intended to be used as sources of food or human therapeutics including excipients, devices, drugs, or biological products.

FOI Summary

EA

FONSI
November 25, 2020 ANADA 200-557 Dechra Veterinary Products LLC Tzed™ 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
November 16, 2020 NADA 141-541 QBiotics Group Ltd. STELFONTA® Dogs For use in dogs for the treatment of:
1) non-metastatic cutaneous mast cell tumors
2) non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock.		 FOI Summary

 

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