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Case Detail


Response to DDMAC Warning Letters to Astellas Pharma US, Inc.
(Regulatory Proceeding)
On September 13, 2006, WLF wrote to DDMAC, calling on DDMAC to withdraw a warning letter sent to Astellas Pharma US, Inc. on August 31 regarding Astellas's allegedly improper promotion of Prograf, a drug approved by FDA for combating organ rejection among patients receiving liver or kidney transplants. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate and violated the First Amendment because Astellas's claims were fully substantiated: they were based on a peer-reviewed study published in a leading medical journal. WLF said that DDMAC's actions were particularly ironic, given that FDA has actually accepted the study for inclusion in the approved product labeling for Prograf.
Case Status:
Awaiting FDA Response.
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