Transmitted by Facsimile
نویسنده
چکیده
The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed a professional sales aid (AT39696) for Strattera (atomoxetine HCl) (Strattera) submitted by Eli Lilly and Company (Eli Lilly) under cover of Form FDA 2253. This piece is false or misleading because it broadens the indication for and overstates the efficacy of Strattera, omits material facts, and minimizes important risks associated with Strattera. Thus, the promotional material misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. 352(a) & 321(n), and FDA’s implementing regulations. Cf. 21 CFR 201.100(c)(1); 201.128; & 202.1(e)(6)(i). These violations are concerning from a public health perspective because they suggest that Strattera is safer and more effective than has been demonstrated.
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