FDA approves new antimicrobial drug for canine infections

Photo courtesy of Felixvet

Officials with the FDA have approved an oral lincosamide antibiotic for canines. Clindamycin Hydrochloride Tablets (Felixvet Inc.) is indicated to treat skin infections, deep wounds and abscesses, dental infections and osteomyelitis caused by susceptible bacterial strains, according to the manufacturer. The drug has demonstrated activity against bacteria such as Staphylococcus aureus, Staphylococcus intermedius, Bacteroides fragilis and Clostridium perfringens.¹

The newly approved therapy from Felixvet offers generic bioequivalence to Antirobe (Zoetis) clindamycin hydrochloride capsules. However, Felixvet’s product is manufactured in tablet dosage form, rather than capsule.²

“With the approval of Clindamycin Hydrochloride Tablets, we’re expanding access to a trusted treatment option that veterinarians rely on for managing common yet potentially serious infections,” Vince Palasota, President of North America at Felixvet, said in a news release.¹ “This product reflects our ongoing commitment to quality, affordability and clinical relevance.”

According to the FDA, bioequivalence was demonstrated in a study that compared the 150 mg Clindamycin Hydrochloride Tablets to the 150 mg Antirobe capsule. Thirty dogs between the ages of 6 months and 5 years were enrolled in the randomized, masked study.²

“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 a dvm360 interview. “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.”

Felixvet representatives noted that Clindamycin Hydrochloride Tablets is considered a “value-added generic,” which differs from a traditional generic product in that something has been changed. Palasota said creating a flavored chewable instead of recreating an unflavored chewable is an example of a value-added generic product. “We're taking the pioneer’s product, and we made some differentiation in the marketplace to try to do what we can do increase compliance with the pet or [provide] something different for the pet owner,” Palasota said in the interview.

“Clindamycin is a proven, versatile therapeutic, and we’re proud to add it to our growing portfolio,” Palasota added in the release.¹ “We look forward to continuing to deliver solutions that meet the daily needs of veterinarians and their patients.”

Clindamycin Hydrochloride Tablets will be available only through a prescription. The product will be supplied as 25 mg tablets in 400-count bottles, 75 mg tablets in 200-count bottles, and 150 mg tablets in 100-count bottles.² 

Patients are dosed with Clindamycin Hydrochloride Tablets every 12 hours. The duration of treatment varies by infection type, typically a few days for acute infections and up to 28 days for osteomyelitis, according to Felixvet.¹

According to Felixvet, the company currently holds more than 20 FDA approvals and has a development pipeline with approximately 70 products in development, including 30 in stages along accelerated paths towards 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 of new generics,” Palasota said in an interview with dvm360.

References

1. Felixvet receives FDA approval for Clindamycin Hydrochloride Tablets. News release. Felixvet. September 22, 2025.
2. Freedom of Information Summary: ANADA 200-813. FDA. June 27, 2025. Accessed September 22, 2025. https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17171