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Case Detail


Response to DDMAC Warning Letter to Mallinckrodt, Inc.
(Regulatory Proceeding)
On November 6, 2006, WLF wrote to DDMAC, calling on DDMAC to withdraw a warning letter sent to Mallinckrodt, Inc. on October 13 regarding Mallinckrodt's allegedly improper promotion of Gastroview (a drug for use in connection with x-rays of the gastrointestinal tract) and OptiMARK (an injection for use with MRIs). DDMAC alleged that exhibit booth panels for the drugs were false and misleading because they failed to provide information regarding risks associated with use of the drugs. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate because the exhibit booth panels clearly stated that company officials in the booth were available to provide full risk information. WLF argued that the availability of a company representative in the immediate vicinity provided adequate access to all risk information and ensured that no one would be misled regarding risks.
Case Status:
Awaiting FDA response.
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