FDA-CVM Recent Companion Animal Drug Approvals

Below is a list of recent companion animal drug approvals from the FDA’s Center for Veterinary Medicine.

Date

Sponsor Product Name Species Indications for Use/Effect of the Supplement

Public Documents

11/20/2019

Norbrook Labs, Ltd. Selarid™

Dogs & cats

For dogs 6 weeks of age and older: Kills adult fleas and prevents flea eggs from hatching for 1 month, and it is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and treatment and control of ear mite (Otodectes cynotis) infestations. Treatment and control of sarcoptic mange (Sarcoptes scabiei) and control of tick infestations due to Dermacentor variabilis. For cats 8 weeks of age and older: Kills adult fleas and prevents flea eggs from hatching for 1 month, and it is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and treatment and control of ear mite (Otodectes cynotis) infestations. Treatment and control of intestinal hookworm (Ancylostoma tubaeforme) and roundworm (Toxocara cati) infections.

FOI Summary

11/14/2019

Intervet, Inc. BRAVECTO® PLUS

Cats

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage larvae, immature adults, and adults) and hookworm (Ancylostoma tubaeforme, 4th stage larvae, immature adults, and adults); kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations (Ixodes scapularis (black-legged tick)) and Dermacentor variabilis (American dog tick)) for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb. or greater.

FOI Summary

10/29/2019

Mizner Bioscience LLC Clomipramine Hydrochloride Tablets

Dogs

Clomipramine Hydrochloride Tablets are to be used as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.

FOI Summary

9/3/2019

Elanco US Inc. Credelio™

Dogs

This supplement provides for the addition of the indication for the prevention of flea infestations (Ctenocephalides felis) for one month in dogs and puppies 8 weeks of age and older and weighing 4.4 lb. or greater.

FOI Summary

7/2/2019

Zoetis Inc. ProHeart® 12

Dogs

For use in dogs 12 months of age and older for the prevention of heartworm disease caused by Dirofilaria immitis for 12 months. For the treatment of existing larval and adult hookworm (Ancylostoma caninum and Uncinaria stenocephala) infections.

FOI Summary

Click here to read the full FDA announcement, including recent animal drug approvals for livestock and production animals.