Market Updates, Products & Ingredients, Regulations

ChromaDex Gains TGA Approval for Nicotinamide Riboside Chloride in Australia

Company receives market exclusivity for two years as it expands presence in the Asia-Pacific region.

ChromaDex Corp. has received approval from the Australian Therapeutic Goods Administration (TGA) for its patented nicotinamide riboside chloride (NR) for use in listed complementary medicines. The listing indicates that ChromaDex has market exclusivity of NR through Dec. 2, 2021.
 
With this approval, ChromaDex will be listing its final product as a complementary medicine on the Australian Register of Therapeutic Goods (ARTG).
 
“This is an important milestone as we expand our presence in the Asia-Pacific region,” said ChromaDex CEO Rob Fried. “We look forward to sharing the unparalleled science behind our ingredient with the people of Australia in 2020.”
 
Cells can use NR to create nicotinamide adenine dinucleotide (NAD), which is an essential molecule found in every living cell. NAD plays an essential role in cellular energy production and supporting cellular repair. Decreased NAD levels are associated with many age-related declines in overall health.
 
Niagen is the only commercially available NR which has twice been successfully reviewed under U.S. Food & Drug Association’s (FDA) new dietary ingredient (NDI) notification requirement and has also been successfully notified to the FDA as generally recognized as safe (GRAS). In August, the European Food Safety Authority (EFSA) issued a positive opinion on Nicotinamide Riboside (NR) as a novel food ingredient for use in a food supplement; in November, the European Commission voted in favor of listing nicotinamide riboside chloride as a novel food. 
 
To date, ChromaDex has invested millions of dollars in safety and human clinical trials on its patent-protected NR and has entered research agreements with more than 170 leading research institutions, including Dartmouth, the National Institutes of Health, University of Iowa, and the Scripps Research Institute.

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