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| | FDA Warning Letter, Loprox (ciclopirox) 0.77% Cream and Lotion (Site not responding. Last check: 2007-10-10) |
 | | As part of our routine monitoring program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has become aware of promotional materials for Loprox (ciclopirox) 0.77% cream and lotion by Medicis Pharmaceutical Corp. (Medicis) that violate the Federal Food, Drug and Cosmetic Act and its implementing regulations. |
 | | It has been shown to have fungistatic, fungicidal, sporicidal, and anti-inflammatory properties and to be active against gram-negative and gram-positive bacteria. |
 | | It is a substituted hydroxypyvidone with a structure different from other antifungal preparations." Furthermore, you state, “This mode of action makes ciclopirox an appropriate choice for topical treatment alone, or as concomitant treatment when a topical product is indicated in combination with an oral antifungal drug. |
| www.pharmcast.com /WarningLetters/Mar2000/Medicis0300.htm (839 words) |
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