Case Detail

Response to DDMAC Warning Letter to Allergan, Inc.
(Regulatory Proceeding)
On June 15, 2007, WLF wrote to DDMAC, calling on DDMAC to withdraw a Warning Letter sent to Allergan, Inc. on May 25 regarding Allergan's allegedly improper promotion of Acular LS, an ophthalmic solution approved for treating ocular pain following corneal refractive surgery. DDMAC's letter to Allergan alleged that a professional journal advertisement for Acular LS misled readers by broadening the drug's indications beyond the indications approved by FDA and by including unsubstantiated superiority claims. WLF's response stated that a fair reading of the advertisement makes clear that Allergan was not claiming that Acular LS had been approved for uses other than those specifically approved by FDA. WLF also charged that DDMAC is violating Allergan's First Amendment rights by rejecting Allergan's right to present truthful information about its product so long as the information is accompanied by appropriate disclaimers.
Case Status:
Awaiting FDA Response.
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