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www.fdanews.com/articles/63588-bradley-s-polyphenon-e-ointment-approved-by-fda

BRADLEY'S POLYPHENON E OINTMENT APPROVED BY FDA

November 1, 2006

Bradley Pharmaceuticals announced that MediGene received FDA approval to market Polyphenon E Ointment, 15 percent, a new topical drug indicated for the treatment of external genital warts. The product, developed by MediGene, will be commercialized in the United States by Bradley starting during the second half of 2007.

Both Bradley operating units will promote the ointment, with the Doak Dermatologics subsidiary marketing it to dermatologists and Bradley's Kenwood Therapeutics division marketing it to the OB/GYN specialty.

The active ingredient in Polyphenon E Ointment is a defined mixture of catechins extracted from green tea and proven effective for the treatment of external genital warts caused by certain strains of human papilloma virus. Current treatment for this condition primarily consists of cryosurgery and the topical therapy Aldara (imiquimod). Polyphenon E Ointment is the first new treatment since Aldara was introduced in 1997.