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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 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
August 26, 2024 ANADA 200-783 Huvepharma EOOD Coxidin 90 (monensin Type A medicated article) Broiler chickens, laying hen replacement chickens, layer breeder replacement chickens, growing turkeys, and growing Bobwhite quail Broiler and Laying Hen Replacement Chicken and Layer Breeder Replacement Chicken: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. 
Turkeys: For the prevention of coccidiosis in turkeys caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis. 
Quail: For the prevention of coccidiosis in growing Bobwhite quail caused by Eimeria dispersa and E. lettyae.		 FOI Summary
August 15, 2024 ANADA 200-770 Pharmgate Inc. MGA and Deracin (melengestrol acetate Type A medicated article and chlortetracycline Type A medicated article) Growing beef heifers fed in confinement for slaughter and replacement beef and dairy heifers
  1. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in growing beef heifers fed in confinement for slaughter.
  2. For suppression of estrus (heat), and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in replacement dairy heifers less than 20 months of age and replacement beef heifers.
  3. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and the reduction of the incidence of liver abscesses in growing beef heifers fed in confinement for slaughter over 400 lbs.
  4. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline in growing beef heifers fed in confinement for slaughter.
  5. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in growing beef heifers fed in confinement for slaughter.
  6. For suppression of estrus (heat), and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline in replacement dairy heifers less than 20 months of age and replacement beef heifers.
  7. For suppression of estrus (heat), and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline in replacement dairy heifers less than 20 months of age and replacement beef heifers.
  8. For suppression of estrus (heat), and control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in replacement beef heifers over 700 pounds.
  9. For suppression of estrus (heat) and control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in replacement beef heifers under 700 pounds.
 FOI Summary
July 8, 2024 ANADA 200-771 Norbrook Laboratories Ltd. Felanorm (methimazole) Cats For the treatment of hyperthyroidism in cats. FOI Summary
July 2, 2024 ANADA 200-788 Bimeda Animal Health Ltd. MoxiSolv Injection (moxidectin) Beef and nonlactating dairy cattle For the treatment and control of internal and external parasites of cattle. FOI Summary
June 20, 2024 ANADA 200-784 ZyVet Animal Health, Inc. Trimeprazine with Prednisolone Dogs Antipruritic: Trimeprazine with Prednisolone is recommended for the relief of itching regardless of cause. Its usefulness has been demonstrated for the relief of itching and the reduction of inflammation commonly associated with most skin disorders of dogs such as the eczema caused by internal disorders, otitis, and dermatitis (allergic, parasitic, pustular, and nonspecific). It often relieves pruritis which does not respond to other therapy.
Antitussive: Trimeprazine with Prednisolone has been found to be effective therapy and adjunctive therapy in various cough conditions of dogs. Therefore, in addition to its antipruritic action, Trimeprazine with Prednisolone is recommended for the treatment of “kennel cough” or tracheobronchitis, bronchitis including all allergic bronchitis, and infections and coughs of nonspecific origin. (Coughs due to cardiac insufficiency would not be expected to respond to Trimeprazine with Prednisolone therapy).		 FOI Summary
June 17, 2024 ANADA 200-785 Felix Pharmaceuticals Pvt. Ltd. Maropitant Citrate Tablets  Dogs For the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs. FOI Summary
June 11, 2024 ANADA 200-787 ZyVet Animal Health, Inc. Phenylpropanolamine Hydrochloride Dogs For the control of urinary incontinence due to urethral sphincter hypotonus in dogs. FOI Summary
June 4, 2024 NADA 138-255 Sparhawk Laboratories, Inc. IRON DEXTRAN 20% INJECTION Swine, nursing piglets This supplement provides for a new strength (200 mg/mL) and dose (200 mg/piglet) of the injectable solution. FOI Summary
May 23, 2024 NADA 131-675 Intervet Inc. Safe-Guard (fenbendazole) Wild quail This supplement provides for the addition of wild quail with the indication for the treatment and control of Aulonocephalus spp. in wild quail. FOI Summary
May 16, 2024 ANADA 200-781 Cronus Pharma Specialities India Private Ltd. Flunine (flunixin meglumine injection)  Horses, beef cattle, and dairy cattle (excluding dry dairy cows) Horse: For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse. 
Cattle: For the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. It is also indicated for the control of inflammation in endotoxemia.		 FOI Summary
May 10, 2024 NADA 141-577 Vetoquinol USA, Inc. UpCard-CA1 (torsemide oral solution) Dogs For use with concurrent therapy with pimobendan, spironolactone, and an angiotensin converting enzyme (ACE) inhibitor for the management of pulmonary edema in dogs with congestive heart failure caused by myxomatous mitral valve disease (MMVD). FOI Summary
May 9, 2024 ANADA 200-782 Cronus Pharma Specialities India Private Ltd. EnroPro Silver Otic (enrofloxacin/silver sulfadiazine) Dogs As a treatment for canine otitis externa complicated by bacterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine. FOI Summary
May 8, 2024 ANADA 200-780 Aurora Pharmaceutical, Inc. CocciAid for Calves (amprolium) Beef and dairy calves An aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zurnii in calves. FOI Summary
April 26, 2024 NADA 141-582 Warburton Technology Ltd. MULTIMIN 90 (zinc, copper, manganese, and selenium) Cattle. Not for use in pregnant cows and heifers during their first trimester because reproductive safety testing has not been done in these animals. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety has not been established.  To provide a supplemental source of zinc, copper, manganese, and selenium in cattle. Not for use in pregnant cows and heifers during their first trimester because reproductive safety testing has not been done in these animals. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety has not been established. FOI Summary
April 25, 2024 ANADA 200-728 Cronus Pharma Specialities India Private Ltd. Pimomedin (pimobendan)  Dogs For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis. FOI Summary
April 10, 2024 ANADA 200-777 Felix Pharmaceuticals Pvt. Ltd. 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
April 9, 2024 NADA 141-550 Elanco US Inc. Pradalex (pradofloxacin) Cattle: For use in cattle intended for slaughter (beef calves 2 months of age
and older, growing beef steers, growing beef heifers, and beef bulls intended for slaughter), and in cattle intended for breeding less than 1 year of age (replacement beef and dairy heifers less than 1 year of age and beef and dairy bulls less than 1 year of age). Not for use in cattle intended for breeding 1 year of age and older (replacement beef and dairy heifers 1 year of age and older, beef and dairy bulls 1 year of age and older, and beef and dairy cows), beef calves less than 2 months of age, dairy calves, and veal calves.
Swine: For use in weaned swine intended for slaughter (nursery, growing, and finishing swine, boars intended for slaughter, barrows, gilts intended for slaughter, and sows intended for slaughter). Not for use in swine intended for breeding (boars intended for breeding, replacement gilts, and sows intended for breeding) and in nursing piglets.		 Cattle: For the treatment of BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in cattle intended for slaughter (beef calves 2 months of age and older, growing beef steers, growing beef heifers, and beef bulls intended for slaughter), and in cattle intended for breeding less than 1 year of age (replacement beef and dairy heifers less than 1 year of age and beef and dairy bulls less than 1 year of age). Not for use in cattle intended for breeding 1 year of age and older (replacement beef and dairy heifers 1 year of age and older, beef and dairy bulls 1 year of age and older, and beef and dairy cows), beef calves less than 2 months of age, dairy calves, and veal calves.
Swine: For the treatment of SRD associated with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae in weaned swine intended for slaughter (nursery, growing, and finishing swine, boars intended for slaughter, barrows, gilts intended for slaughter, and sows intended for slaughter). Not for use in swine intended for breeding (boars intended for breeding, replacement gilts, and sows intended for breeding) and in nursing piglets.
 		 FOI Summary
April 5, 2024 NADA 141-043 Zoetis Inc. SYNOVEX Choice and SYNOVEX PRIMER (trenbolone acetate and estradiol benzoate) Growing beef steers and heifers in a dry lot This supplement provides for the approval of a new indication to SYNOVEX Choice for increased rate of weight gain in growing beef steers and heifers in a dry lot; and, adds the approval of SYNOVEX PRIMER for increased rate of weight gain in growing beef steers and heifers in a dry lot. FOI Summary

FONSI

EA
March 15, 2024 NADA 141-579 Dechra, Ltd. DuOtic (terbinafine and betamethasone acetate) Dogs For the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis). FOI Summary
March 1, 2024 ANADA 200-772 Parnell Technologies Pty. Ltd. CONTRASED (atipamezole hydrochloride) Dogs For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs. FOI Summary

 

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