Rare Skin Allergy Warning Spreads To Nexium 24HR
FDA approves request after Nexium 24HR marketer Haleon responded March to changes-being-effected letter asking for label change to the delayed-release PPI.
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A better than expected first-half performance has put Haleon on a sure footing for the rest of the year following its recent demerger from GSK.
Already providing generic equivalents, Perrigo buys national brand from GSK as it acts on commitment to move into brand product sales. Plans to expand OTC Prevacid line, likely with an orally disintegrating tablet, and to grow entire US OTC gastrointestinal category.
Final US guidance adds CHPA's suggestion for an example for a warning on labeling for products containing both acetaminophen and aspirin, needed to highlight where “Allergy Alert” and “Liver Warning” statements are on those products' labels.