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GlucoWatch G2 Biographer Expands Label To Include Pre-Treatment Products That Minimize Skin Irritation

REDWOOD CITY, Calif., March 18 /PRNewswire-FirstCall/ -- Cygnus, Inc. (BULLETIN BOARD: CYGN) today announced that the U. S. Food and Drug Administration (FDA) approved Cygnus' pre-market approval (PMA) application supplement for the expansion of the labeling to include a description of pre-treatment products and a method to minimize the effects of skin irritation without affecting the accuracy of G2(R) Biographer glucose measurements.

Clinical data submitted by Cygnus showed a significant reduction in irritation with pre-treatment with Kenalog(R) (Westwood-Squibb Pharmaceuticals, Inc., Buffalo, NY) aerosol spray and Cortizone-10 Quick Shot(R) (Pfizer Inc., New York, NY) spray.

"We are pleased with the FDA's approval of this label expansion. Though most users only experience mild skin irritation from the G2 Biographer, providing an approved means to minimize skin irritation is great news for our current and prospective customers," stated John C Hodgman, Chairman, CEO and President of Cygnus. "This approval is particularly gratifying, as it comes on the heels of the FDA's approval of our third-generation Biographer. We are committed to making GlucoWatch(R) Biographer products increasingly user-friendly, and these two approvals are a testament to this effort," he added.

Source: Cygnus, Inc.

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