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Case Detail


Response to DDMAC Untitled Letter to WellSpring
(Regulatory Proceeding)
On January 29, 2007, WLF wrote to DDMAC, calling on DDMAC to withdraw an untitled letter sent to WellSpring Pharmaceutical Corp. on December 19, 2006 regarding WellSpring's allegedly improper promotion of Dyrenium in a professional print advertisement. Dyrenium is a drug approved by FDA for treating edema in a variety of settings. WLF's letter to DDMAC alleged that DDMAC's actions were inappropriate because it lacked any empirical basis for asserting that readers of the ad would think that WellSpring was making a claim that overstated Dyrenium's efficacy, and that nothing in the ad's language readily indicated that WellSpring was making such a claim. WLF also responded that DDMAC may not prohibit all references to clinical studies that conclude that the drug is superior to alternatives; if FDA does not like the study design, it should simply require the ad to mention any potential shortcomings in the study.
Case Status:
Awaiting FDA response.
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