Fortini™ Infant Formula Clears FDA Review; Energy- and Nutrient-dense Formula Aims to Set New Standard in U.S. to Support Growth in Infants with, or at Risk of, Failure to Thrive
Sep 23, 2021, 08:35 ET
ROCKVILLE, Md., Sept. 23, 2021 /PRNewswire/ -- Nutricia North America ("Nutricia") today announced that the U.S. Food and Drug Administration (FDA) has completed its review of its infant nutrition product, Fortini™. The new infant formula supports catch-up growth in infants with, or at risk of, growth failure and those with increased energy requirements or fluid restrictions.
Nutricia is part of Danone North America, a leading food and beverage company with a unique health-focused portfolio that spans the dairy, plant-based, beverage and specialized nutrition categories.
Fortini is specifically created for infants and toddlers (up to 18 months) who need more calories or have high energy needs due to their clinical condition. It is the first and only 30 kcal/fl oz formula in the U.S. that is nutritionally complete, ready-to-feed and specifically calibrated for term infants with undernutrition or failure to thrive. Nutricia has been a global leader in nutrition for 120 years, best known in the U.S. for Neocate®.
All formulas marketed in the United States must meet federal nutritional, growth and safety requirements, and infant formula manufacturers must notify the FDA prior to marketing a new formula. Fortini is backed by seven clinical trials and one retrospective chart review. Fortini has been shown in clinical trials to be well tolerated and supports weight gain and catch-up growth in failure-to-thrive infants under medical supervision.
"We are pleased to introduce Fortini as the newest product in Nutricia's portfolio of specialized medical foods," said Romina Fernandez, General Manager of Nutricia North America. "As a company, our longstanding mission is to help people live longer, more joyful and healthier lives. Fortini helps us to proactively address the needs of infants with, or at risk of, growth failure, and fills a long-standing gap in the infant formula options available in the U.S. for this patient group. While Nutricia supports breastfeeding, wherever possible, Fortini offers additional support to those who may need it."
Until now, there has been no such formula available in the U.S. for term infants with failure to thrive or growth failure. When dietitians and physicians wanted to feed babies a higher caloric concentration of formula, they typically have had to incrementally increase the amount of powdered infant formula beyond intended use, or add modular powders or liquid fats in order to achieve such a high calorie-per-ounce concentration. Risks included mixing errors, unbalanced nutrition, insufficient protein intake and poor tolerance to over-concentrated infant formula. Clinicians also have worried about inadequate hydration from more concentrated formulations. Parents, too, may have worried about making mixing mistakes or finding special recipes difficult to follow.
Anca M. Safta, MD, a pediatric gastroenterologist and associate professor in the Department of Pediatrics, Wake Forest University School of Medicine in Winston-Salem, NC, who participated in a key clinical trial, commented, "At Wake Forest, we felt it was important to be included as a site to study this energy- and protein-enriched formula in infants with poor growth. Being able to see first-hand that our patients with growth failure due to cardiac and non-cardiac etiologies were able to tolerate this formula, gain weight and thrive was very exciting."
Fortini is intended for use at the recommendation of a physician, nurse or dietitian and must be used under medical supervision. It will be available to physicians, and registered dietitians across the U.S. by the end of September 2021. Nutricia also aims to have Fortini available by clinician recommendation to families who qualify for WIC and Medicaid within the first year of launch.
Since 1896, Nutricia has pioneered nutritional solutions that help people live longer, more joyful and healthier lives. Building on more than a century of research and innovation, Nutricia has harnessed the power of life-changing nutrition to create a leading specialized nutrition portfolio that can change a health trajectory for life.
With its nutritional solutions, Nutricia supports healthy growth and development during a baby's first 1,000 days and helps to address some of the world's biggest health challenges, including in North America: faltering growth, food allergy, rare metabolic diseases, epilepsy and wound healing.
As part of Danone North America, Nutricia embraces the company's "One Planet. One Health" vision reflecting that the health of people and the health of the planet are interconnected and therefore seeks to protect and nourish both.
For more information visit www.FortiniUS.com. Photos available upon request.
Ivy Cohen Corporate Communications
Share this article