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. |
|
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 |