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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
February 24, 2023 ANADA 200-741 Aurora Pharmaceutical, Inc. EpriGard Beef and dairy cattle, including lactating dairy cattle For the treatment and control of gastrointestinal roundworms (including
inhibited Ostertagia ostertagi), lungworms, grubs, sucking and biting lice, chorioptic and sarcoptic mange mites, and horn flies.		 FOI Summary
February 9, 2023 ANADA 200-701 Chanelle Pharmaceuticals Manufacturing Ltd. PARASEDGE Multi for Cats Ferrets This supplement provides for the addition of the following indications for ferrets: For the prevention of heartworm disease in ferrets caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations on ferrets. FOI Summary
February 2, 2023 ANADA 200-739 ZYVET AH, Inc. Carprofen 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
February 2, 2023 ANADA 200-737 ZYVET AH, Inc. Enrofloxacin Dogs and cats For the management of diseases associated with bacteria susceptible to enrofloxacin. FOI Summary
January 13, 2023 ANADA 200-736 ZYVET AH, Inc. Marbofloxacin Dogs and cats For the treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin. FOI Summary
January 13, 2023 ANADA 200-735 ZYVET AH, Inc. Dexmedetomidine Hydrochloride 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
January 12, 2023 ANADA 200-734 Felix Pharmaceuticals Pvt. Ltd. Praziquantel Tablets Dogs For the removal of the following canine cestodes: Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus and for the removal and control of
Echinococcus multilocularis.		 FOI Summary
January 12, 2023 ANADA 200-733 Felix Pharmaceuticals Pvt. Ltd. Marbofloxacin Chewable Tablets Dogs and cats For the treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin. FOI Summary
January 12, 2023 ANADA 200-721 Norbrook Laboratories Ltd. Midamox for Cats Ferrets This supplement provides for the addition of the following indications for ferrets: For the prevention of heartworm disease in ferrets caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations on ferrets. FOI Summary
January 12, 2023 NADA 141-426 Intervet, Inc. BRAVECTO Dogs 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 dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater. FOI Summary
January 11, 2023 ANADA 200-738 Aurora Pharmaceutical, Inc. DectoGard Cattle For the treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and sucking lice, horn flies, and mange mites in cattle. FOI Summary
January 11, 2023 ANADA 200-611 Akorn Operating Company LLC DetomiSed Horses For use as a sedative and analgesic to facilitate minor surgical and diagnostic 
procedures in mature horses and yearlings.		 FOI Summary
January 5, 2023 ANADA 200-732 Felix Pharmaceuticals Pvt. Ltd. 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
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

 

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