BioCentury
ARTICLE | Clinical News

EvaMist regulatory update

December 5, 2011 8:00 AM UTC

FDA updated the label of EvaMist estradiol metered-dose transdermal spray to include a boxed warning that breast budding, breast masses and gynecomastia have been reported in children following unintentional secondary exposure to the drug. Acrux licensed EvaMist to Vivus, which subsequently granted U.S. marketing rights to KV Pharmaceutical Co. (NYSE:KV-A, Bridgeton, Mo.). KV markets EvaMist to treat moderate to severe vasomotor symptoms due to menopause. ...