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 |
|---|---|---|---|---|---|---|
| October 29, 2021 | ANADA 200-628 | Sparhawk Laboratories, Inc. | ENROFLOXACIN 100 | Beef cattle, non-lactating dairy cattle, and swine | Cattle - Single-Dose Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and nonlactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis. Cattle - Multiple-Day Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and nonlactating dairy cattle. Swine: For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. It is also indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed. |
FOI Summary |
| October 29, 2021 | NADA 141-348 | Zoetis Inc. | SYNOVEX® ONE Grower | Growing beef steers and heifers fed in confinement for slaughter | This supplement provides for approval of the indication for increased rate of weight gain for up to 200 days in growing beef steers and heifers fed in confinement for slaughter. | |
| October 28, 2021 | ANADA 200-588 | Sparhawk Laboratories, Inc. | FLORFENICOL INJECTION | Beef and non-lactating dairy cattle | For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and for the treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus. Also, it is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. |
FOI Summary |
| October 20, 2021 | ANADA 200-604 | Dechra Veterinary Products LLC | Amoxicillin and Clavulanate Potassium for Oral Suspension | 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, Pasteurella multocida, and Pasteurella spp. Urinary tract infections (cystitis) due to susceptible strains of E. coli. |
FOI Summary |
| October 1, 2021 | ANADA 200-691 | Virbac AH, Inc. | RAC™ 45 CATTLE | Cattle fed in confinement for slaughter | Complete Feed: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in cattle fed in confinement for slaughter during the last 28 to 42 days on feed. Top Dress Feed: For increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter during the last 28 to 42 days on feed. |
FOI Summary |
| 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 |