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Veregen Approval History

FDA Approved: Yes (First approved October 31, 2006)
Brand name: Veregen
Generic name: kunecatechins
Dosage form: Ointment
Previous Name: Polyphenon E
Company: MediGene AG
Treatment for: Condylomata Acuminata

Veregen(kunecatechins) contains a concentrate of catechines extracted from green tea leaves. Veregen is indicated for the treatment of external genital and perianal warts.

Development History and FDA Approval Process for Veregen

DateArticle
Oct 31, 2006Approval Polyphenon E MediGene AG - Treatment for Genital and Perianal Warts
Jun 30, 2006FDA Extends PDUFA Date for Polyphenon E Ointment to October 31, 2006
Dec  1, 2005MediGene Announces FDA Acceptance of New Drug Application for Polyphenon E Ointment for the Treatment of Genital Warts

Further information

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