Animal & Veterinary

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
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, 2018 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, 2018 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
October 15, 2018 NADA 141-485 Zoetis Inc. COYDEN® and LINCOMIX® Broiler chickens As an aid in the prevention of cecal and intestinal coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens. FOI Summary
October 1, 2018 ANADA 200-490 Dragon Fire Holding Co., Inc. 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
August 10, 2018 NADA 141-488 Zoetis Inc. Avatec® and LINCOMIX® Broiler chickens For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens. FOI Summary
August 9, 2018 ANADA 200-630 Aurora Pharmaceutical, LLC CocciAid™ Growing chickens, turkeys and laying hens For the treatment of coccidiosis. FOI Summary
August 8, 2018 NADA 141-439 Elanco US Inc. Inteprity™ Broiler chickens This supplement provides for a change in the broiler chicken age restriction caution statement from 10 days to 18 days as follows: To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age.

FOI Summary

EA

FONSI

August 3, 2018 NADA 141-461 Aratana Therapeutics, Inc. NOCITA® Cats This supplement provides for use as a peripheral nerve block to provide regional postoperative analgesia following onychectomy in cats. FOI Summary

 

Page Last Updated: 02/01/2019
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English