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Dolizem Approval Status

  • FDA approved: No
  • Brand name: Dolizem
  • Generic name: diltiazem hydrochloride
  • Dosage form: Topical Cream
  • Company: Ventrus Biosciences
  • Treatment for: Anal Fissure and Fistula

Dolizem (diltiazem) is an investigational topical calcium-channel blocker applied perianally to treat pain related to anal fissure.

Development Status and FDA Approval Process for Dolizem

Apr  4, 2014Ventrus Biosciences Receives Date for Type B Pre-NDA Meeting With FDA for Dolizem
Feb 12, 2014Ventrus Biosciences Announces Results From Second Pivotal Phase 3 Trial of Diltiazem Cream (VEN 307) in Patients With Anal Fissure
May 14, 2012Ventrus Biosciences Announces Positive Results From Pivotal Phase 3 Trial of Diltiazem (VEN 307) in Patients With Anal Fissures

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