Recent Animal Drug Approvals
Drug Approval Information
Approved Animal Drug Products (Green Book Online)
Animal Drugs@FDA
Freedom of Information (FOI) Summaries for Approved and Conditionally 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 |
|---|---|---|---|---|---|---|
| December 22, 2023 | ANADA 200-765 | Cronus Pharma Specialities India Private Ltd. | EnroPro 100 (enrofloxacin) | 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 non-lactating 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 non-lactating 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. For the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed. |
FOI Summary |
| December 22, 2023 | ANADA 200-764 | Cronus Pharma Specialities India Private Ltd. | EnroPro 22.7 (enrofloxacin) | Dogs | For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin. | FOI Summary |
| December 22, 2023 | ANADA 200-762 | Cronus Pharma Specialities India Private Ltd. | Carofenvet (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 |
| December 21, 2023 | ANADA 200-760 | Cronus Pharma Specialities India Private Ltd. | Florfeniject (florfenicol) | 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 |
| December 14, 2023 | NADA 141-502 | Zoetis Inc. | revolution PLUS (selamectin and sarolaner) | Cats | This supplement provides for the addition of the indication for the treatment and control of tick infestations with Amblyomma americanum (lone star tick) for one month in cats and kittens 8 weeks and older, and weighing 2.8 pounds or greater. | FOI Summary |
| November 17, 2023 | NADA 141-580 | Orion Corp. | Bonqat (pregabalin) | Cats | For alleviation of acute anxiety and fear associated with transportation and veterinary visits in cats. | FOI Summary |
| November 8, 2023 | ANADA 200-758 | Felix Pharmaceuticals Pvt. Ltd. | Enrofloxacin | 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 non-lactating 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 non-lactating 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; and for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed. |
FOI Summary |
| October 20, 2023 | NADA 141-564 | Pharmgate Inc. | Pennchlor and Rumensin (chlortetracyclinel and monensin) | Replacement beef and dairy heifers | This supplement provides for the addition of replacement beef and dairy heifers with the following indications: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline and for the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii in replacement beef and dairy heifers; and For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline and for increased rate of weight gain in replacement beef and dairy heifers. |
FOI Summary |
| October 13, 2023 | NADA 141-336 | ECO LLC | AIVLOSIN (62.5% w/w tylvalosin as tylvalosin tartrate) | Female swine intended for breeding (replacement gilts, gestating replacement gilts, gestating sows, lactating sows, and weaned sows) | This supplement provides for the addition of female swine intended for breeding (replacement gilts, gestating replacement gilts, gestating sows, lactating sows, and weaned sows) to the classes approved for the control of porcine proliferative enteropathy and control of swine respiratory disease indications, and provides for removal of the precaution “Not for use in lactating or pregnant females or females intended for breeding” from the labeling. | FOI Summary |
| October 11, 2023 | NADA 141-572 | Virbac AH, Inc. | AYRADIA (metronidazole) | Dogs | For the treatment of Giardia duodenalis infection in dogs. | FOI Summary |
| September 20, 2023 | ANADA 200-310 | Parnell Technologies Pty. Ltd. | estroPLAN (cloprostenol) | Lactating dairy cows | This supplement provides for the addition of the indication “For use with gonadorelin to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows.” | FOI Summary |
| September 6, 2023 | NADA 141-578 | Genus Lifesciences Inc. | FIDOQUEL-CA1 (phenobarbital) | Dogs | Conditionally approved for the control of seizures associated with idiopathic epilepsy in dogs. | FOI Summary |
| August 31, 2023 | ANADA 200-757 | ZyVet Animal Health, Inc. | Acepromazine Maleate Tablets | Dogs | As an aid in tranquilization and as a preanesthetic agent in dogs. Acepromazine Maleate Tablets can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures. | FOI Summary |
| August 10, 2023 | NADA 141-568 | Boehringer Ingelheim Animal Health USA, Inc. | Senvelgo (velagliflozin) | Cats | To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin. | FOI Summary |
| August 3, 2023 | ANADA 200-755 | Felix Pharmaceuticals Pvt. Ltd. | Firocoxib (firocoxib) | Dogs | For the control of pain and inflammation associated with osteoarthritis and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery. | FOI Summary |
| August 3, 2023 | ANADA 200-756 | Ceva Sante Animale | Firodyl (firocoxib) | Dogs | For the control of pain and inflammation associated with osteoarthritis and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery. | FOI Summary |
| July 19, 2023 | NADA 141-554 | Boehringer Ingelheim Animal Health USA, Inc. | NexGard PLUS (afoxolaner, moxidectin, and pyrantel) | Dogs | For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) and roundworm (Toxocara canis and Toxascaris leonina) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), and Amblyomma americanum (lone star tick) infestations for one month in dogs and puppies eight weeks of age and older, weighing four pounds of body weight or greater. |
FOI Summary |
| July 11, 2023 | ANADA 200-753 | Cronus Pharma Specialities India Private Ltd. | Cropamezole (atipamezole hydrochloride) | Dogs | For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs. |
FOI Summary |
| July 6, 2023 | ANADA 200-752 | Cronus Pharma Specialities India Private Ltd. | DexmedVet (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 |