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Case Detail


Response to DDMAC Warning Letter to Enzon Pharmaceuticals, Inc.
(Regulatory Proceeding)
On June 11, 2007, WLF wrote to DDMAC, calling on DDMAC to withdraw a Warning Letter sent to Enzon Pharmaceuticals, Inc. on May 21, 2007 regarding an Enzon flash card for Abelcet, a drug approved for treatment of invasive fungal infections. DDMAC stated that the flash card was misleading because it made unsubstantiated superiority claims and overstated the efficacy of Abelcet. WLF responded that DDMAC lacked any empirical basis for asserting that readers would think that Enzon was claiming that Abelcet is superior to competing products. WLF further argued that DDMAC violated Enzon's First Amendment rights in seeking to bar any discussion of in vitro data that support Enzon's efficacy claims. WLF argued that DDMAC is entitled to insist on disclaimers that note the shortcomings of in vitro data, but that it may not seek to bar all mention of the data.
Case Status:
Awaiting FDA response.
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