FDA Warns AstraZeneca On Crestor Marketing

For the second time in four months, the Food and Drug Administration's Division of Drug Marketing, Advertising, and Communications (DDMAC) has warned AstraZeneca on advertisements promoting its cholesterol drug Crestor.

This time the FDA's complaints focus on claims in television and print ads that Crestor is the most effective statin. In a letter sent to AstraZeneca, an officer at DDMAC noted that the efficacy of Crestor's top 40-milligram dose was similar to that of 80 milligrams of Lipitor in the study referenced by AstraZeneca.

"The TV and print ads make false or misleading claims regarding the superiority of Crestor," Christine Smith, a regulatory review officer at DDMAC wrote in the letter.