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Dificid FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2020.

FDA Approved: Yes (First approved May 27, 2011)
Brand name: Dificid
Generic name: fidaxomicin
Company: Merck
Treatment for: Clostridioides difficile Infection

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

Development timeline for Dificid

Jan 27, 2020Approval FDA Approves Merck‚Äôs Dificid (fidaxomicin) to Treat Clostridioides difficile in Children Aged Six Months and Older
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

Further information

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