- Cronus Pharma’s Robenacoxib Injection is the first FDA-approved generic bioequivalent to Onsior Injection, according to the company.
- The NSAID is indicated for postoperative pain and inflammation associated with soft tissue surgery in dogs at least 4 months of age.
- In cats at least 4 months of age, indications include orthopedic surgery, ovariohysterectomy and castration.
- Treatment is limited to a maximum of three days in both dogs and cats.
- The product is supplied as a 20 mg/mL solution in a 20 mL multidose vial and was approved under ANADA #200-804.
- Robenacoxib Injection is now available through national and regional veterinary distributors across the United States.
Veterinarians have a new generic option for injectable robenacoxib following the U.S. launch of Cronus Pharma’s Robenacoxib Injection, the first FDA-approved bioequivalent to Onsior Injection.
Cronus Pharma announced that the prescription nonsteroidal anti-inflammatory drug is now available through national and regional veterinary distributors across the United States.
The product was approved by the U.S. Food and Drug Administration under Abbreviated New Animal Drug Application (ANADA) #200-804. Onsior (robenacoxib) Injection is the reference listed new animal drug.
Postoperative pain indications in dogs and cats
Cronus Pharma’s Robenacoxib Injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs 4 months of age and older.
For cats 4 months of age and older, the drug is indicated for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration.
Treatment is limited to a maximum of three days in both dogs and cats.
The injectable product contains robenacoxib at a concentration of 20 mg/mL and is supplied in a 20 mL multidose vial.
“Addressing post-operative pain is imperative in both dogs and cats,” Scott A. Krick, DVM, consulting technical services veterinarian at Cronus Pharma, said in the announcement. “The launch of Robenacoxib Injection from Cronus Pharma provides a cost-effective NSAID option and reflects our commitment to expanding access to FDA-approved bioequivalent medications that support veterinarians, their patients, and pet owners.”
New generic expands injectable robenacoxib options
The launch gives veterinary practices a new generic bioequivalent option for injectable robenacoxib within the approved indications.
Cronus Pharma said the addition is part of its effort to expand access to FDA-approved bioequivalent veterinary medications and provide veterinarians with additional treatment choices.
“The launch of Robenacoxib Injection marks an important addition to Cronus Pharma’s growing portfolio of FDA-approved veterinary products,” said Janel Fisher, vice president of sales at Cronus Pharma. “This launch demonstrates our ability to turn that commitment to innovation into solutions that provide greater choice and value for the veterinary community.”
Important prescribing information
Federal law restricts Robenacoxib Injection to use by or on the order of a licensed veterinarian.
The drug should not be used for more than three days or in animals younger than 4 months of age.
According to the safety information included in the announcement, serious adverse events, including hepatopathy, have been reported with long-term use of robenacoxib tablets in dogs during a 28-day study.
Onsior Injection is a registered trademark of Elanco US Inc.
Information sourced from the company’s press release.
