Accera statement on FDA warning letter
January 14, 2014
Accera responds to the recent FDA warning letter
Broomfield, CO, January 14, 2014 – Accera, Inc., is a science-based company specializing in research and development for innovative products, including products to address the dietary management of challenging neurodegenerative diseases such as Alzheimer’s disease.
Accera recently received a warning letter from the FDA regarding the company’s product, Axona®, as a medical food. The letter from the FDA primarily addressed the positioning of Axona as a medical food and certain website claims. A detailed, documented, and comprehensive response to the FDA’s letter is being drafted by Accera.
Accera is working with the FDA, and welcomes the chance for correspondence with the FDA in order to address the agency’s questions relating to Axona.