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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
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
May 25, 2021 NADA 140-269 Zoetis Inc. KETOFEN® Cattle: beef heifers, beef steers, beef calves two months of age and older, beef bulls, replacement dairy heifers, and dairy bulls This supplement provides for the addition of a new target animal and indication to the label. FOI Summary
May 18, 2021 NADA 141-452 Zoetis Inc. Simparica® Dogs This supplement provides for the addition of the indication, “for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.” FOI Summary
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

 

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