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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
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
July 29, 2020 ANADA 200-687 Cronus Pharma Specialities India Private 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
July 27, 2020 NADA 141-538 Ceva Sante Animale Cardalis™ Dogs With concurrent therapy (e.g., furosemide, etc.) for the management of clinical signs of mild, moderate, or severe congestive heart failure in dogs due to atrioventricular valvular insufficiency (AVVI). FOI Summary
July 9, 2020 NADA 141-532 Intervet, Inc. BRAVECTO® 1-MONTH Dogs Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick) and Rhipicephalus sanguineus (brown dog tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater.
It is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for one month in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater.
FOI Summary

 

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