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Veregen FDA 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 Timeline 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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