Elanco Announces Credelio Quattro Moves to Final FDA Administrative Review

Product Development and Approval - The company's broad-spectrum parasiticide, Credelio Quattro, is on track for U.S. FDA approval in October 2024, with a targeted launch in the first quarter of 2025 [1] - The FDA has completed its review of all major and minor technical sections for Credelio Quattro, and the final 60-day administrative review is underway [1] - Credelio Quattro is expected to be positively differentiated, with approval sought for indications providing the broadest parasite coverage, including fleas, ticks, heartworms, and other internal parasites like tapeworm [2] - The company is finalizing the manufacturing scale-up to optimize the launch of Credelio Quattro [2] Innovation and Pipeline - The company expects to launch a potential blockbuster product each of the next three quarters in large, fast-growing, or new markets, contributing significantly to its revenue [2] - The company anticipates $600 million to$700 million in innovation sales for 2025 [2] - The company has two potential blockbuster products, Zenrelia and Credelio Quattro, in the final administrative review at the FDA, showcasing its R&D organization's high capacity and ability to deliver consistent high-impact innovation [3] - The company completed the Bovaer review ahead of schedule, further demonstrating its innovation capabilities [3] Company Overview - Elanco Animal Health is a global leader in animal health, dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets [4] - The company has nearly 70 years of animal health heritage and is committed to improving the health of animals, creating value for farmers, pet owners, veterinarians, and society as a whole [4] - Elanco's vision is "Food and Companionship Enriching Life," and it is driven by its Elanco Healthy Purpose™ sustainability pillars to advance the health of animals, people, the planet, and the enterprise [4] FDA Approval Process - The FDA's Center for Veterinary Medicine (CVM) approves and regulates new animal drugs, with the approval process including up to five major technical sections and two minor technical sections [3] - Once all technical sections are complete, the drug sponsor submits the New Animal Drug Application (NADA) for the final administrative review [3]