Amplimune an alternative for herd health as FDA further restricts antibiotics


As the US Food & Drug Administration (FDA) heads toward full implementation of its plan for supporting veterinary antimicrobial stewardship, NovaVive Inc. offers an antibiotic alternative for cattle.

Amplimune® is an emulsion of mycobacterium cell wall fraction (MCWF) that is regulator-approved in the USA, Canada, New Zealand and the United Arab Emirates to reduce the clinical signs and mortality associated with E. coli K99 diarrhea in neonatal calves. When injected into the animal, Amplimune enhances both innate and adaptive immune responses to fight bacterial infections, without the use of antibiotics.

Amplimune is OMRI listed in the USA and Canada for use in organic production. Research with Amplimune has demonstrated safety and efficacy for:

  • improving average daily gain in hutch-reared calves
  • reducing mortality and drug use in veal calves
  • reducing the risk of pneumonia in shipped calves
  • improving pregnancy in embryo transfer recipient heifers
  • reducing disease/improving fertility of dairy cows
  • reducing morbidity and mortality in highly stressed feedlot calves
  • an adjunct therapy alongside traditional treatments

Effective in June, 2023, all over-the-counter (OTC) bovine antibiotics will be switched to prescription-only status. The antibiotics currently without a “for veterinary use only” in OTC locations will be required to add the new label or be removed from the market.

The FDA evaluates the safety of drugs used in food-producing animals, the impact drug residues have on human intestinal microflora, and the development of human antimicrobial resistance. Drug residues in meat, milk, eggs, and honey from treated animals expose bacteria to trace amounts that don’t kill them, but rather allow for the development of antibiotic resistance. Veterinarians are tasked to slow the rate of bacterial resistance by using antibiotics only when necessary to treat, control, or prevent disease. Doing so preserves antibiotic efficacy for humans and animals.

Under the new rule, producers with current veterinary client-patient relationships may purchase antibiotics directly from their veterinarian or from a distributor with the vet’s prescription. Amplimune does not require a veterinarian prescription.

About NovaVive Inc.

NovaVive is a private company founded in July, 2014. The Company has an advanced veterinary immunotherapeutic platform based on mycobacterium cell wall fraction (MCWF) technology with 5 regulator-approved products in the USA (three of these are regulator-approved in Canada; two in Australia; three in New Zealand; and two in the UAE). The Company’s development plan is to identify additional livestock and companion animal diseases that may be effectively treated with its immunotherapeutic technology platform.