Generic antimicrobial product is approved by the FDA

A new antimicrobial generic drug was approved by FDA officials for the treatment of canine skin infections: cefpodoxime proxetil tablets by Felixvet, a pharmaceutical manufacturer based in Ireland.1,2 This product is bioequivalent to Zoetis' Simplicef.1

Cefpodoxime proxetil tablets are indicated for wounds and abscesses caused by Staphylococcus pseudintermedius, Staphylococcus aureus, Streptococcus canis (group G, β hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.1,2 A third-generation cephalosporin, the drug interferes with the production of bacterial cell walls, thereby killing vulnerable bacteria.2

The generic product is available in 100 mg and 200 mg active ingredient strengths. Each tablet strength is supplied in 100- and 250-count bottles.1,2

The recommended dose range for cefpodoxime proxetil tablets is 2.3 to 4.5 mg/lb (approximately 5-10 mg/kg) body weight, according to the FDA. Cefpodoxime proxetil tablets are indicated to be administered once daily for 5 to 7 days or for 2 to 3 days beyond the cessation of clinical signs. If there is no visible response to treatment of acute infection, cefpodoxime proxetil tablets should not be continued for more than 3 to 4 days.1

“Felixvet is committed to providing affordable options without sacrificing quality or reliability. We adhere to rigorous FDA standards, ensuring safety and efficacy in every product,” Vince Palasota, president of Felixvet’s North America headquarters in Kansas City, Missouri, said in a news release.2

Felixvet conducted a single in vivo blood-level study in canines to demonstrate the bioequivalence to Simplicef, with no serious adverse events reported in relation to the administration of these drugs. The company also conducted a comparative in vivo dissolution study for an additional product strength at 200 mg. Based on the dissolution data, the FDA granted a biowaiver for the 200-mg strength.1

Felixvet has a history of developing “value-added” generic drugs. These therapies differ from traditional generic products in that they are not direct recreations of an original drug. For example, the company’s clindamycin hydrochloride tablets, an oral antibiotic recently approved by the FDA, are flavored, unlike its branded counterpart.3

According to Felixvet, the company currently holds more than 20 FDA approvals and is developing approximately 70 additional products, including 30 in stages along accelerated paths toward approval. “When you think of generic drugs in the animal health marketplace, there's only about 12% of the marketplace that has been genericized. So, there's a world of opportunities [for] new generics,” Palasota said in an interview with dvm360.3

Clindamycin hydrochloride tablets are indicated for treating skin infections, deep wounds, and abscesses, as well as dental infections and osteomyelitis caused by susceptible bacterial strains. Bioequivalent to Zoetis' Antirobe, the drug has demonstrated activity against bacteria such as S aureus, Staphylococcus intermedius, Bacteroides fragilis, and Clostridium perfringens.3

“Clindamycin is an incredibly important anti-infective, or antimicrobial, for the management of multiple different infectious diseases and infectious conditions in pets,” Douglas Shane, DVM, PhD, veterinary director at Felixvet, said in an interview with dvm360.3 “So, we're just going to continue to bring that Felix value to our vet clinics so that they have another partner for them, in their practices, they go [for] this widely used antimicrobial.”

References

1. Recent animal drug approvals. FDA. Accessed October 31, 2025. https://www.fda.gov/animal-veterinary/approved-animal-drug-products-green-book/recent-animal-drug-approvals#:~:text=Proteus%20mirabilis.-,FOI%20Summary,-July%208%2C%202025
2. Felixvet receives FDA approval for cefpodoxime proxetil tablets. News release. Felixvet. October 30, 2025.
3. Crossley KC. FDA approves new antimicrobial drug for canine infections. dvm360. September 22, 2025. Accessed October 31, 2025. https://www.dvm360.com/view/fda-approves-new-antimicrobial-drug-for-canine-infections