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ARTICLE | Company News

DDMAC Corlopam letter

March 1, 2000 8:00 AM UTC

ELN's Elan Pharmaceuticals division received a letter dated Feb. 15 from the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) regarding three promotional pieces for ELN's Corlopam fenoldopam that DDMAC said lacked fair balance and contained unapproved uses and cost effectiveness claims. The product is marketed for in-hospital, short-term management of severe hypertension when rapid, but quickly reversible, emergency reduction of blood pressure is clinically indicated. ...