Orapem FDA Approval Status

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

Development timeline for Orapem

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

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