Drug Approval Information
Approved Animal Drug Products (Green Book Online)
Freedom of Information (FOI) Summaries for Approved Animal Drugs (FOI Summary)
Environmental Assessments/Findings of No Significant Impact (EA/FONSI)
Medicated Feed (Blue Bird) Labels
|Date||Application Number||Sponsor||Product Name||Species||Indications for Use/Effect of the Supplement||Public Documents|
|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.
|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.
|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.
|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.
|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|
|June 22, 2023||ANADA 200-751||Pegasus Laboratories, Inc.||Firocoxib Chewable Tablets for Dogs (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 in dogs.||FOI Summary|
|June 21, 2023||NADA 141-406||Boehringer Ingelheim Animal Health USA, Inc.||NexGard (afoxolaner)||Dogs||This supplement provides for a new modified NexGard formulation.
This supplement provides for the addition of the indication for the treatment and control of Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for one month.
This supplement also provides for the addition of label language regarding the improvement of erythema, alopecia, papules, scales, crusts, and excoriation in dogs with flea infestations and signs of Flea Allergy Dermatitis following treatment with NexGard, as a direct result of eliminating fleas.
|June 9, 2023||NADA 141-555||Zoetis Inc.||apoquel chewable (oclacitinib)||Dogs||Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.||FOI Summary|
|June 9, 2023||ANADA 200-117||Bimeda Animal Health Ltd.||Oxytetracycline Injection (oxytetracycline)||Beef cattle, non-lactating dairy cattle, and swine||This supplement provides information to address the human food safety and user safety of N-methyl-2-pyrrolidone (NMP) in the formulation of Oxytetracycline Injection, and provides for alignment with Guidance for Industry (GFI) #263, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter.”||FOI Summary|