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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
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
October 29, 2020 ANADA 200-692 Virbac AH, Inc. CYCLAVANCE™ Dogs For the control of atopic dermatitis in dogs weighing at least 4 lbs (1.8 kg) body weight. FOI Summary
October 16, 2020 NADA 141-536 Elanco US Inc. Elura™ Cats For management of weight loss in cats with chronic kidney disease. FOI Summary
September 29, 2020 ANADA 200-528 Pharmgate, Inc. Savalan® 60 Broiler, roaster, and replacement (breeder and layer) chickens, and quail Broiler, roaster and replacement (breeder and layer) chickens: For the prevention of coccidiosis in broiler, roaster and replacement chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati.
Quail: For the prevention of coccidiosis in quail caused by Eimeria dispersa and E. lettyae.
FOI Summary
September 28, 2020 ANADA 200-069 Bimeda Animal Health Ltd. OvaCyst® Lactating dairy cows and beef cows This supplement provides for a new estrous reproductive synchronization indication “OvaCyst® is indicated for use with cloprostenol sodium to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows and beef cows.” FOI Summary
September 18, 2020 ANADA 200-690 Pharmasone LLC ZoaShield™ 25% Broiler and replacement chickens and growing turkeys Broiler Chickens: For prevention and control of coccidiosis
Replacement Chickens: For development of active immunity to coccidiosis
Growing Turkeys: For prevention and control of coccidiosis
FOI Summary
September 9, 2020 NADA 141-529 Pharmgate, Inc. Pennitracin MD® and Maxiban™ Broiler chickens For increased rate of weight gain and improved feed efficiency, 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 4, 2020 ANADA 200-681 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

 

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