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Veregen Approval History

  • FDA approved: Yes (First approved October 31st, 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

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

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