FDA CVM Veterinary Medicine Updates

Generic Omeprazole Oral Paste Approved for Horse Gastric Ulcers

The FDA approved Gastrobim (omeprazole) oral paste as a generic equivalent to Gastrogard for the treatment and prevention of gastric ulcers in horses and foals four weeks of age and older. Sponsored by Bimeda Animal Health Ltd. of Ireland, the drug was determined bioequivalent to the brand-name product approved in 1999. Gastrobim is available only by prescription from a licensed veterinarian.

FDA Indexes New Drug for Ornamental Finfish Parasites

The FDA has added Prazi-Med, a praziquantel powder for immersion, to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. This drug treats internal and external parasites in ornamental finfish, providing a faster and less expensive pathway to market for such products.

FDA Approves First Generic Florfenicol and Flunixin Injection

The FDA has approved nixiFLOR, the first generic version of florfenicol and flunixin meglumine injection for treating bovine respiratory disease. This approval marks a new generic option for beef and non-lactating dairy cattle, with a withdrawal period of 38 days.

FDA Guidance on Defining Drug Use Durations for Medically Important Antimicrobials

The FDA has finalized guidance (GFI #273) recommending how animal drug sponsors can voluntarily establish defined durations of use for medically important antimicrobial drugs administered in feed to food-producing animals. Over 100 drugs are affected, and sponsors are expected to submit revised labeling within approximately three years.

FDA Authorizes Drugs for New World Screwworm in Dogs and Cats

The FDA has issued two Emergency Use Authorizations (EUAs) for NexGard and NexGard COMBO for the treatment of New World screwworm infestations in dogs and cats, respectively. These EUAs are effective until the HHS Secretary terminates the public health emergency declaration for this pest.

FDA Issues Emergency Use Authorization for F10 Antiseptic Wound Spray for New World Screwworm

The FDA has issued an Emergency Use Authorization (EUA) for F10 Antiseptic Wound Spray with Insecticide for the prevention and treatment of New World screwworm in multiple animal species, excluding domestic dogs and cats. This authorization allows for broader use than previously approved products, with specific food safety guidelines for treated animals.

FDA Issues Emergency Use Authorization for Ivomec to Prevent Screwworm in Cattle

The FDA has issued an Emergency Use Authorization (EUA) for Ivomec (ivermectin) injectable solution to prevent New World screwworm infestations in cattle. This authorization allows for over-the-counter use under specific conditions and is effective until the declared emergency is terminated.