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Recent Animal Drug Approvals

Recent Animal Drug Approvals


Drug Approval Information

Approved Animal Drug Products (Green Book Online)
Animal Drugs@FDA 
FOIA Drug Summaries (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
May 30, 2019 ANADA 200-537 Bimeda Animal Health Ltd. OxyMed™ LA Swine, beef cattle, dairy cattle, and calves including preruminating (veal) calves Cattle: For the treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp.; infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis; foot rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona; and wound infections and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline.
Swine: For the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona. In sows, OxyMed™ LA is indicated as an aid in the control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.
FOI Summary
May 21, 2019 NADA 141-514 Elanco US Inc. Experior™ and Rumensin™ Beef steers and heifers fed in confinement for slaughter 1) For reduction of ammonia gas emissions per pound of live weight and hot carcass weight and prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.
2) For reduction of ammonia gas emissions per pound of live weight and hot carcass weight and improved feed efficiency in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.
FOI Summary
May 21, 2019 NADA 141-512 Elanco US Inc. Experior™ and Rumensin™ and Tylan™ Beef steers and heifers fed in confinement for slaughter 1) For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii, and reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.
2) For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, improved feed efficiency, and reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.
FOI Summary
May 16, 2019 ANADA 200-598 Bimeda Animal Health Limited EnroMed™ 100 Cattle (beef and non-lactating dairy) 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
May 7, 2019 ANADA 200-633 Pharmgate Inc. Denagard® and Deracin® Swine For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin and for treatment of swine bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis sensitive to chlortetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida sensitive to chlortetracycline. FOI Summary
May 6, 2019 NADA 141-288 Zoetis Inc. EXCENEL® RTU EZ Swine This supplement provides for an increase in the maximum injection site volume in swine from 5 mL to 15 mL. The larger maximum injection site volume will reduce the number of injections needed in larger pigs. FOI Summary
April 11, 2019 NADA 140-989 Syndel USA PARASITE-S Freshwater-reared finfish This supplement provides for the addition of the following indication: For the control of mortality in freshwater-reared finfish due to saprolegniasis associated with fungi in the family Saprolegniaceae. FOI Summary
March 29, 2019 NADA 141-517 Pegasus Laboratories, Inc. PROIN ER™ Dogs For the control of urinary incontinence due to urethral sphincter hypotonus in dogs. FOI Summary
February 8, 2019 NADA 141-297 Boehringer Ingelheim Animal Health USA Inc. ProZinc® Dogs This supplement provides for the addition of the indication for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs with diabetes mellitus. FOI Summary
February 4, 2019 ANADA 200-637 Provetica AH LLC Doxidyl™ Dogs For the control of pain and inflammation associated with osteoarthritis in dogs, for the control of postoperative pain and inflammation associated with orthopedic surgery in dogs, and for the control of postoperative pain and inflammation associated with dental surgery in dogs. FOI Summary
January 31, 2019 ANADA 200-450 Bimeda Animal Health Ltd. Bimectin® Plus Cattle For the treatment and control of internal parasites, including adult liver flukes, and external parasites. FOI Summary
January 28, 2019 ANADA 200-616 Norbrook Laboratories, Ltd. Cefenil® RTU Swine and cattle Swine: For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis.
Cattle: For treatment of the following bacterial diseases:
1. Bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
2. Acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
3. Acute metritis (0 to 14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.
FOI Summary
December 19, 2019 ANADA 200-629 Ceva Sante Animale MilbeGuard™ Dogs and cats For use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control of adult Toxocara canis and Toxascaris leonina (roundworms) and Trichuris vulpis (whipworm) infections in dogs and in puppies four weeks of age or greater and two pounds body weight or greater.

For use in the prevention of heartworm disease caused by Dirofilaria immitis, and the removal of adult Ancylostoma tubaeforme (hookworm) and Toxocara cati (roundworm) in cats and kittens six weeks of age or greater and 1.5 lbs. body weight or greater.
FOI Summary
December 4, 2019 NADA 141-509 Boehringer Ingelheim Vetmedica, Inc. Pexion™ Dogs Pexion™ tablets are indicated for treatment of noise aversion in dogs. FOI Summary