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Adeona Executes Manufacturing and Supply Agreement with TG United for reaZin™
Date:4/20/2011

ements, based on recognized scientific principles, are established by medical evaluation.

In general, to be considered a medical food, a product must, at a minimum, meet the following criteria (according to the Food & Drug Administration (FDA) and the U.S. Congress, as part of the Orphan Drug Act):

  • The product must be a food for oral or tube feeding
  • The product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements
  • The product must be intended to be used under medical supervision
  • Ingredients of the product must have GRAS (Generally Recognized As Safe) status or be FDA-approved as food additives
  • The product must comply with FDA regulations that pertain to labeling, product claims, and manufacturing

Adeona is developing reaZin, its product candidate for the dietary management of Alzheimer's disease and mild cognitive impairment, as a prescription medical food.

Reference:

(1) Guidance for Industry: Frequently Asked Questions About Medical Foods. U.S. Food & Drug Administration website. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/MedicalFoods/ucm054048.htm. May 1997; Revised May 2007; Accessed April 2011.

About reaZin

reaZin, formerly named Zinthionein, is a proprietary, gastroretentive, sustained release, once-daily oral tablet formulated from zinc (150 mg) and cysteine (100 mg), an amino acid with potent anti-oxidant properties. reaZin was developed by Adeona to achieve the following: 1) the convenience of a once-daily dose, 2) high oral bioavailability (the quantity or fraction of the ingested dose that is absorbed by the body) and 3) the
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SOURCE Adeona Pharmaceuticals, Inc.
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