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July 20, 2011

FDA Clears Graceway Skin Cream

Graceway Pharmaceuticals has received US Food and Drug Administration approval for Zyclara (imiquimod) cream, 2.5% for the treatment of actinic keratoses. Zyclara 3.75% cream is also indicated for the treatment of external genital warts. In four double-blind studies conducted

By cms admin

Graceway Pharmaceuticals has received US Food and Drug Administration approval for Zyclara (imiquimod) cream, 2.5% for the treatment of actinic keratoses.

Zyclara 3.75% cream is also indicated for the treatment of external genital warts.

In four double-blind studies conducted to evaluate imiquimod 2.5% or 3.75% versus a placebo, patients applying imiquimod 2.5% ‘on a two weeks on, two weeks off, two weeks on’ dosing cycle experienced the fewest local skin reactions of any of the treatment groups.

Some 31% of patients using imiquimod 2.5% cream had complete clearance of actinic keratoses, versus 6% for the placebo group.

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