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Case Detail


Response to DDMAC Warning Letter to Sankyo Pharma Inc.
(Regulatory Proceeding)
On January 17, 2006, WLF wrote to DDMAC, calling on DDMAC to withdraw a warning letter sent to Sankyo Pharma Inc. on January 6 regarding Sankyo's allegedly improper promotion of Benicar in connection with a sales aid it distributed. Benicar and Benicar HCT are angiotensin II receptor antagonists approved by FDA for treating hypertension. DDMAC alleged that in making superiority claims, Sankyo relied on studies that FDA did not deem "well-controlled." WLF's response charged that FDA is violating the First Amendment in attempting to prohibit all mention of the studies, whose truthfulness FDA does not challenge. At most, FDA may require a manufacturer that cites truthful information from reputable journals to include disclaimers pointing out potential shortcomings in the studies, WLF said.
Case Status:
Awaiting FDA response.
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