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Optimer Pharmaceuticals Announces FDA Acceptance of NDA for Filing and Designation of Priority Review for Fidaxomicin for the Treatment of Clostridium difficile Infection (CDI)
Date:1/24/2011

SAN DIEGO, Jan. 24, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for reducing the risk of recurrence when used for treatment of initial CDI. The FDA has also granted the Company's request for six-month Priority Review, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. Additionally, the FDA has informed us that it plans to discuss the NDA at a meeting of its Anti-Infective Drugs Advisory Committee currently scheduled for April 5, 2011.

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The acceptance of the fidaxomicin NDA for filing confirms the FDA's determination that the NDA is sufficiently complete to permit a substantive review.  A Priority Review classification is granted to drugs that, if approved, have the potential to provide significant improvements compared to marketed treatments, or provide a treatment where no satisfactory alternative therapy exists. A Priority Review means that the goal for the time it takes the FDA to review a new drug application is reduced. Based on this classification, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011 for its review of the NDA.

"In Phase 3 clinical trials, fidaxomicin not only showed a high clinical cure rate, but also demonstrated a statistically significant improvement in reducing recurrences, one of the major problems in the current management of CDI," said Pedro Lichtinger, Optimer's President and CEO.  "The agency's acceptance of our NDA represents a step forward to fulfill an unmet medical need and support
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SOURCE Optimer Pharmaceuticals, Inc.
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