First generic robenacoxib injectable is FDA-approved for postoperative use in dogs and cats

Officials with the FDA have approvedthe first generic robenacoxib injectable (Robenacoxib Injection; Cronus Pharma Specialties) for the control of postoperative pain and inflammation in canine and feline patients. The drug is indicatedfor postoperative pain and inflammation associated with soft tissue surgery in dogs, and for postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats.¹

Robenacoxib Injection is used in dogs and cats aged 4 months and older, and is bioequivalent to the brand-name product Onsior injection (Elanco Animal Health), Both Robenacoxib Injection and Onsior injection contain the active ingredient robenacoxib. Onsior injection was first approved by the FDA for dogs in 2016 and cats in 2015.¹

Robenacoxib Injection is a nonsteroidal anti-inflammatory drug (NSAID). It is available by prescription from a veterinarian and distributed in 20 mL multidose vials. The drug can be administered with a dose of 0.91 mg/lb once daily for up to 3 days in both cats and dogs, according to the FDA.^1,2

In felines, the first dose of Robenacoxib Injection “should be administered approximately 30 minutes prior to surgery, at the same time as the preanesthetic agents are given,” the FDA wrote in its Freedom of Information (FOI) Summary for the product.² “Subsequent doses can be given via subcutaneous injection or interchanged with an oral tablet for cats—which will have a different dose than the Robenacoxib Injection for felines—in patients weighing 5.5 lbs or more.”

In canines, the first dose of Robenacoxib Injection “should be administered approximately 45 minutes prior to surgery, at the same time as the preanesthetic agents are given,” according to the FOI summary. “Subsequent doses can be given via subcutaneous injection or interchanged with an oral tablet for dogs weighing 5.5 lbs or more.” However, different injection sites should be used for subsequent subcutaneous injections.²

In January 2026, the FDA announced the approval of the first generic robenacoxib tablet for control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats. Sponsored by ZyVet Animal Health, this product is also bioequivalent to an Onsior brand product from Elanco.³

ZyVet’s robenacoxib tablet is available with a prescription from a veterinarian. The drug is FDA-approved for a 0.45 mg/lb dose.³

References

1. FDA approves first generic robenacoxib injectable for postoperative pain and inflammation in dogs and cats. News release. FDA. March 9, 2026. Accessed March 9, 2026. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-robenacoxib-injectable-postoperative-pain-and-inflammation-dogs-and-cats?utm_medium=email&utm_source=govdelivery
2. Freedom of Information (FOI) Summary: ANADA 200-804. FDA. https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/18230
3. FDA approves generic drug product for feline postoperative pain. dvm360. January 9,2026. Accessed March 9, 2026. https://www.dvm360.com/view/fda-approves-generic-drug-product-for-feline-postoperative-pain