FDA finalizes guidance for topical, injectable antibiotics used in animals
The Food and Drug Administration (FDA) announced today that it has finalized guidelines to bring the remaining medically important antibiotics still sold over-the-counter (OTC) for use in animals under the supervision of veterinarians.
The finalization of guidance for industry (GFI) #263 means that the roughly 4% of medically important antibiotics that are currently marketed as OTC products for use in livestock and companion animals will require a prescription from a licensed veterinarian going forward. It builds on previous FDA guidance (GFI #213), which brought 96% of all medically important antibiotics used in animal water and feed under veterinary supervision and limited their use to treatment, control, or prevention of specific diseases.
The remaining 4% of medically important antibiotics not covered by GFI #213 include other dosage forms, such as injectables and topicals. The new guidance outlines the process for animal drug sponsors to voluntarily change the labels on these products from OTC to prescription.
The FDA says the new guidelines will be implemented over a 2-year timeframe.
“The agency is committed to working with affected stakeholders to facilitate the transition process and to minimize impacts on animal health,” the agency said in a press release. “During the two-year timeframe for implementation recommended in GFI #263, FDA plans to work with affected stakeholders and state partners to answer questions about the voluntary transition process and provide assistance where possible.”
Jun 10 FDA press release
BARDA grants additional funding for rapid antibiotic susceptibility test
Selux Diagnostics announced this week that it has been awarded an additional $14.6 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) to commercialize its Next Generation Phenotyping (NGP) platform for rapid antibiotic susceptibility testing (AST).
BARDA granted the additional funding after Selux completed its first clinical trial, which confirmed the NGP platform’s ability to provide rapid, accurate AST results for a wide array of antibiotics from cultured isolates. Selux plans to submit the clinical results to the FDA to begin the process of commercialization.
BARDA has now awarded a total of $60.8 million to Selux to support the project.
“A global crisis of antibiotic resistance requires innovation to save lives, and we believe this next generation technology represents the future backbone of microbiology,” Selux CEO Steve Lufkin said in a company press release. “Our plan is to build on the success of this first clinical study and turn our attention to the next phase of product development to speed the time to targeted antibiotic treatment further, preserving the lifesaving power of antibiotics for future generations.”
Jun 8 Selux press release