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Genital Warts

New drug application filed with U.S. Food and Drug Administration for Polyphenon E Ointment

Published in Medical Letter on the CDC and FDA, November 6th, 2005

MediGene AG (MDG) announced that it has submitted a new drug application (NDA) for its Polyphenon E Ointment for the treatment of genital warts to the U.S. Food and Drug Administration (FDA).

MediGene owns the worldwide marketing rights for the drug and is planning submission for marketing authorization in Europe next year.

Polyphenon E Ointment, the active substance in Polyphenon E Ointment, is a concentrate of catechines with a defined composition, extracted from green tea leaves. MediGene is developing this drug for the treatment of various skin tumors. For the indication genital warts, MediGene estimates the sales potential of this drug at more...

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