Medicis and Dow Pharmaceutical Sciences Announce FDA Approval of Ziana

Medicis and Dow Pharmaceutical Sciences Inc announced that the U.S. Food and Drug Administration has approved ZIANA (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel.

ZIANA Gel is the first and only combination of clindamycin and tretinoin approved for once daily use for the topical treatment of acne vulgaris in patients 12 years or older.

ZIANA Gel is also the first and only approved acne product to combine an antibiotic and a retinoid.

ZIANA Gel contains clindamycin phosphate 1.2% and tretinoin 0.025%, formulated as a cosmetically elegant topical gel.

ZIANA Gel has an alcohol-free, aqueous base. Medicis expects product supply to be available for shipping to wholesalers in the fourth quarter of 2006, and anticipates promotion and sample distribution of ZIANA Gel to physicians shortly thereafter.

ZIANA Gel is protected by U.S. Patent No. 6,387,383, both a composition of matter and a method patent, which expires in 2020. Additionally, U.S. Patent No. 5,721,275, a composition of matter patent, has been placed before the U.S. Patent and Trademark Office to be reissued. Each of these patents covers aspects of the unique vehicle which are used to deliver the active ingredients in ZIANA Gel.

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