Healthy Skepticism Library item: 10214

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: report

Warning Letter to Enzon Pharmaceuticals re Abelcet (Amphotericin B Lipid Complex Injection) Marketing
: US FDA 2007 May 21
http://www.fda.gov/CDER/warn/2007/Abelcet_wl.pdf

Abstract:

…The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a flash
card (ABL 100-059-0806) for Abelcet (Amphotericin B Lipid Complex Injection) submitted by Enzon
Pharmaceuticals, Inc. (Enzon) under cover of Form FDA-2253. The flash card is misleading because it
presents unsubstantiated superiority claims and overstates the efficacy of Abelcet. Thus, the flash card misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §352(a), and FDA implementing regulations. Cf. 21 CFR 202.1(e)(6)(i), (ii), (vii), (x), (xviii); (e)(7)(i). These violations are concerning from a public health perspective because they suggest that Abelcet is more effective than has been demonstrated and encourage its use before other therapeutic options when it is a second line agent…

Notes:

Link to promotional material:
http://www.fda.gov/CDER/warn/2007/Abelcet_Promo.pdf