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Case Detail


Response to DDMAC Warning Letters to Sandoz, Inc. and BIPI
(Regulatory Proceeding)
On June 2, 2006, WLF wrote to DDMAC, calling on DDMAC to withdraw untitled letters sent to Sandoz, Inc. (on May 25) regarding Sandoz's allegedly improper promotion of bupropion) and to BIPI (on May 26) regarding BIPI's allegedly improper promotion of Spiriva Handihaler. DDMAC alleged that a professional print advertisement for bupropion was misleading because it failed to disclose all risk information. DDMAC alleged that a promotional labeling piece for Spiriva was misleading because it stated that another inhalant (Antrovent) was being discontinued in its CFC formulation without mentioning that Antrovent continued to be available in an HFA formulation. WLF's letter to DDMAC alleged that both DDMAC letters were inappropriate and violated the First Amendment because they characterized promotional materials as misleading without a sufficient empirical basis.
Case Status:
Awaiting FDA Response.
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