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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 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 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
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.		 FOI Summary
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
May 25, 2023 ANADA 200-750 Cronus Pharma Specialities India Private Ltd. Doraject (doramectin) Cattle and swine Cattle: Doraject injectable solution is indicated for treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, sucking lice, and mange mites. Doraject injectable solution has been proved to effectively control infections and to protect cattle from reinfection with Cooperia oncophora and Haemonchus placei for 14 days, Ostertagia ostertagi for 21 days, and C. punctata, Oesophagostomum radiatum, and Dictyocaulus viviparus for 28 days after treatment. 
Swine: Doraject injectable solution is indicated for treatment and control of gastrointestinal roundworms, lungworms, kidney worms, sucking lice, and mange mites.		 FOI Summary
May 10, 2023 ANADA 200-748 Huvepharma EOOD Pennchlor and Monovet (chlortetracycline and monensin) Beef calves 2 months of age and older, and growing beef steers and heifers fed in confinement for slaughter
  1. 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 due to Eimeria bovis and Eimeria zuernii in beef calves 2 months of age and older.
  2. For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in growing beef steers and heifers fed in confinement for slaughter over 700 lbs.
  3. For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter over 700 lbs.
  4. 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 due to Eimeria bovis and Eimeria zuernii in growing beef steers and heifers fed in confinement for slaughter.
  5. For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline and for improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter.
  6. For the reduction of the incidence of liver abscesses and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in growing beef steers and heifers fed in confinement for slaughter over 400 lbs.
  7. For the reduction of the incidence of liver abscesses and for improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter over 400 lbs.
  8. For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in growing beef steers and heifers fed in confinement for slaughter under 700 lbs.
  9. For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter under 700 lbs.
  10. For the control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in growing beef steers and heifers fed in confinement for slaughter.
  11. For the control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline and for improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter.
 FOI Summary
May 5, 2023 NADA 141-562 Zoetis Inc. Librela (bedinvetmab) Dogs For the control of pain associated with osteoarthritis in dogs. FOI Summary
May 1, 2023 NADA 141-571 Elanco US Inc. Varenzin-CA1 (molidustat) Cats Conditionally approved for the control of nonregenerative anemia associated with chronic kidney disease (CKD) in cats. FOI Summary

 

 

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