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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
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
November 21, 2018 NADA 038-439 Phibro Animal Health Corp. Terramycin® 100 for Fish and Terramycin® 200 for Fish Freshwater-reared salmonids weighing up to 55 grams Freshwater-reared salmonids weighing up to 55 grams: For marking the skeletal tissue. FOI Summary
November 9, 2018 NADA 141-502 Zoetis Inc. revolution® PLUS Cats revolution® PLUS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis. revolution® PLUS kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the treatment and control of tick infestations with Ixodes scapularis (black-legged tick), Amblyomma maculatum (Gulf Coast tick) and Dermacentor variabilis (American dog tick), the treatment and control of ear mite (Otodectes cynotis) infestations, and the treatment and control of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections for one month in cats and kittens 8 weeks and older, and weighing 2.8 pounds or greater. FOI Summary
November 6, 2018 NADA 141-508 Elanco US Inc. Experior™ Beef steers and heifers fed in confinement for slaughter For reduction of ammonia gas emissions per pound of live weight and hot carcass weight in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed. FOI Summary
EA
FONSI
November 1, 2018 ANADA 200-627 Putney, Inc. Cyclosporine Capsules, USP MODIFIED Dogs Cyclosporine Capsules, USP MODIFIED are indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. FOI Summary