FDA Approves First Generic Amoxicillin and Clavulanate Potassium for Oral Suspension for Use in Cats and Dogs
August 19, 2021
The U.S. Food and Drug Administration has approved the first generic form of amoxicillin and clavulanate potassium for oral suspension for use in cats and dogs. Amoxicillin and Clavulanate Potassium for Oral Suspension is approved to treat susceptible skin and soft tissue bacterial infections (e.g., wounds, abscesses, cellulitis, etc.) in both dogs and cats. It is also approved to treat periodontal (gum) bacterial infections in dogs and urinary tract infections (cystitis) due to susceptible strains of E. coli in cats. The drug is a generic version of Clavamox Drops.
Amoxicillin and Clavulanate Potassium for Oral Suspension contains the same active ingredients in the same concentrations and dosage form as the approved brand name drug product, Clavamox Drops, which was first approved on February 5, 1986. In addition, the FDA determined that Amoxicillin and Clavulanate Potassium for Oral Suspension contains no inactive ingredients that may significantly affect the bioavailability of the active ingredient.
The data submitted in support of the Abbreviated New Animal Drug Application demonstrate that Amoxicillin and Clavulanate Potassium for Oral Suspension, when used according to its label, is safe and effective.
Amoxicillin and Clavulanate Potassium for Oral Suspension is a prescription product because a veterinarian’s expertise is required to diagnose bacterial infections and to determine whether Amoxicillin and Clavulanate Potassium for Oral Suspension is an appropriate treatment.
Amoxicillin and Clavulanate Potassium for Oral Suspension is supplied in 15-mL bottles containing dry powder for reconstitution with water.
Amoxicillin and Clavulanate Potassium for Oral Suspension is sponsored by Cronus Pharma Specialties India Private Ltd. based in India.
Additional Information
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.