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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
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
April 20, 2023 NADA 141-570 Boehringer Ingelheim Animal Health USA, Inc. NexGard COMBO (esafoxolaner, eprinomectin, and praziquantel) Cats For the prevention of heartworm disease caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the treatment and control of Ixodes scapularis (black-legged tick) and Amblyomma americanum (lone star tick) infestations, and the treatment and control of roundworms (fourth stage larval and adult Toxocara cati), hookworms (fourth stage larval and adult Ancylostoma tubaeforme; adult Ancylostoma braziliense), and tapeworms (Dipylidium caninum) in cats and kittens 8 weeks of age and older, and weighing 1.8 lbs or greater. FOI Summary
April 10, 2023 NADA 038-439 Phibro Animal Health Corp. Terramycin 200 for Fish (oxytetracycline) Catfish and freshwater-reared salmonids This supplement provides for the addition of an indication for the control of mortality due to columnaris disease associated with Flavobacterium columnare in catfish and freshwater-reared salmonids. FOI Summary
April 5, 2023 ANADA 200-612 Bimeda Animal Health Ltd. Bimasone (flumethasone) Horses, dogs and cats Bimasone is recommended for the various rheumatic, allergic, dermatologic and other disease states which are known to be responsive to the anti-inflammatory corticoids. FOI Summary
March 31, 2023 ANADA 200-747 ZyVet Animal Health Inc. Maropitant Citrate (maropitant citrate) Dogs For the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs. FOI Summary
March 30, 2023 ANADA 200-746 Norbrook Laboratories Ltd. Tauramox (moxidectin) Beef and nonlactating dairy cattle For the treatment and control of internal and external parasites of cattle. FOI Summary
March 29, 2023 ANADA 200-744 Provetica LLC Modulis for Cats (cyclosporine) Cats For the control of feline allergic dermatitis as manifested by excoriations (including facial and neck), miliary dermatitis, eosinophilic plaques, and self-induced alopecia in cats at least 6 months of age and at least 3 lbs (1.4 kg) in body weight. FOI Summary
March 21, 2023 ANADA 200-745 Parnell Technologies Pty. Ltd. RESPIRmycin 25 (tulathromycin) Swine, suckling calves, dairy calves, and veal calves Swine: For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.
Suckling Calves, Dairy Calves, and Veal Calves: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.		 FOI Summary
March 21, 2023 ANADA 200-743 Provetica LLC Modulis for Dogs (cyclosporine) Dogs For the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. FOI Summary

 

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