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Consumer Health Care New Products Roundup: Unisom SleepMinis, Wolfshot

This article was originally published in The Tan Sheet

Executive Summary

Unisom line extends with SleepMinis; Wolfshot energy tests in US and Canada; Clif Bar launches seasonal flavor; Mediterra adds savory bars; and more news in in brief

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Label Warnings Against Driving Start Arriving For OTC Sleep Ingredients In US

Unisom Sleeptab with 25 mg doxylamine is first OTC sleep remedy adding warning not to drive a vehicle or operate machinery and five others FDA requested in “changes being effected” letter. Agency’s ongoing review found “labeling deficiencies” with doxylamine and diphenhydramine.

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.

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