Wednesday, July 31, 2013

Stocks DD Cites: FDA's love letter to Spectrum Pharma on Zevalin


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FDA sends this letter dated 07/23 to Spectrum pharma on Zevalin marketing practices  ->Full Letter here Link  

Mr. Anil Hiteshi, RAC, 
Vice President, Global Regulatory Affairs 
Spectrum Pharmaceuticals 
157 Technology Drive 
Irvine, CA 92618 
RE: BLA #125019 
ZEVALIN® (ibritumomab tiuxetan) Injection for Intravenous Use 
MA #195 

Dear Mr. Hiteshi: 

As part of its routine monitoring and surveillance program, the Office of Prescription Drug 
Promotion (OPDP), of the U.S. Food and Drug Administration (FDA) has reviewed a 
professional sales aid (0103058300) (sales aid) for ZEVALIN®
 (ibritumomab tiuxetan) Injection for Intravenous Use (Zevalin) submitted by Spectrum Pharmaceuticals, Inc. (Spectrum) under cover of Form FDA 2253. This sales aid is false or misleading because it minimizes important risk information, overstates the efficacy of Zevalin, and omits material facts. Thus, the sales aid misbrands Zevalin in violation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 352(a) & 321(n), and implementing regulation 21 CFR 1.21(a). Cf. 21 CFR 202.1(e)(5)(i), (iii); (e)(6)(i), (x), (xviii).

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