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Case Detail


Response to DDMAC Warning Letter to Medicis Pharmaceutical Corp.
(Regulatory Proceeding)
On January 17, 2006, WLF wrote to DDMAC, calling on DDMAC to withdraw an untitled letter sent to Medicis Pharmaceutical Corp. on January 4 regarding Medicis's allegedly improper promotion of Loprox Shampoo in connection with a patient brochure on its web site. Loprox is a product approved for topical treatment of seborrheic dermatitis in adults. WLF's response took particular issue with DDMAC's efforts to sanction Medicis for the content of its web site, in light of FDA's reneging on a 1996 promise to issue a guidance document on internet promotion. WLF argued that it is inappropriate for FDA to sanction manufacturers for web site content in the absence of meaningful guidance to manufacturers regarding such content. WLF also alleged that DDMAC's criticism of Medicis's risk disclosures was unwarranted because Medicis included all the necessary risk information in the brochure.
Case Status:
Awaiting FDA response.
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