Health Canada clears Vivimind
This article was originally published in The Tan Sheet
Executive Summary
Ovos Natural Health receives a Natural Health Product Number for its homotaurine amino acid supplement, allowing the Laval, Quebec, firm to sell Vivimind at retail in Canada. The issuance from Health Canada, announced Sept. 30, allows Ovos "to move forward with our search for a partner to commercialize Vivimind on a larger scale in Canada," where it previously was available only online, said Roberto Bellini, CEO of parent company Bellus Health. Ovos said it hoped to introduce the cognitive health product in the U.S. in 2010, but still has not received a reply from FDA on its citizen petition asking for permission to market homotaurine, a former investigational new drug candidate, as a new dietary ingredient (1"The Tan Sheet" Aug. 2, 2010)
You may also be interested in...
FDA Clear On Supplement Ingredient Petitions, But Still Fuzzy On Sec. 912
FDA says current dietary supplement regulations make clear that citizen petitions can be filed to request approval of ingredients that were studied in clinical trials and were part of unsuccessful investigational new drug applications
Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings
Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.