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Case Detail


Response to DDMAC Warning Letter to Alcon Laboratories
(Regulatory Proceeding)
On April 27, 2007, WLF wrote to DDMAC, calling on DDMAC to withdraw a Warning Letter sent to Alcon Laboratories, Inc. on April 20, 2007 regarding Alcon's allegedly improper promotion of Ciprodex in a retail sales sheet and a sales aid. Ciprodex is a drug approved by FDA for treating certain infections. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate because it lacked any empirical basis for asserting that readers of certain language in the sales aid would think that Alcon was claiming superiority, and that nothing in that language readily indicates that Alcon was making such a claim. WLF also responded that DDMAC acted improperly in faulting Alcon for citing a study that supported its "less severe pain" claim. WLF also noted that DDMAC was incorrect in asserting that Alcon failed to include all risk information; in fact, the sales sheet and sales aid contained the very information that the Warning Letter asserted was absent.
Case Status:
Awaiting FDA response.
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