Recent Animal Drug Approvals
Drug Approval Information
Approved Animal Drug Products (Green Book Online)
FOIA Drug Summaries (FOI Summary)
Environmental Assessments/Findings of No Significant Impact (EA/FONSI)
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.
|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.
|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
|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|