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Dificid Approval History

  • FDA approved: Yes (First approved May 27th, 2011)
  • Brand name: Dificid
  • Generic name: fidaxomicin
  • Company: Optimer Pharmaceuticals, Inc.
  • Treatment for: Clostridial Infection

Dificid (fidaxomicin) is a macrolide antibacterial drug indicated for the treatment of Clostridium difficile-associated diarrhea.

Development History and FDA Approval Process for Dificid

May 27, 2011Approval FDA Approves Dificid for Clostridium difficile Infection
Apr  6, 2011Optimer Announces that the U.S. Food and Drug Administration's Anti-Infective Drugs Advisory Committee Voted Unanimously to Recommend Approval of Novel Antibiotic Dificid for Treatment of Patients with Clostridium difficile infection (CDI)
Jan 24, 2011Optimer Pharmaceuticals Announces FDA Acceptance of NDA for Filing and Designation of Priority Review for Fidaxomicin for the Treatment of Clostridium difficile Infection (CDI)
Nov 30, 2010Optimer Pharmaceuticals Completes New Drug Application for Fidaxomicin and Requests Priority Review From FDA
Sep 21, 2010Optimer Pharmaceuticals Submits Rolling New Drug Application to FDA for Fidaxomicin

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