Skip to Content

Orapem Approval Status

  • FDA approved: No
  • Brand name: Orapem
  • Generic name: faropenem medoxomil
  • Company: Replidyne, Inc.
  • Treatment for: Bacterial Infection

Development Status and FDA Approval Process for Orapem

Oct 23, 2006U.S. Food and Drug Administration Issues Non-Approvable Letter for Faropenem
Feb 23, 2006Replidyne and Forest Laboratories Announce FDA Acceptance for Review of New Drug Application for Oral Antibiotic Faropenem Medoxomil
Jan  9, 2006Replidyne Submits NDA for Orapem

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.