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Iroko Pharmaceuticals Announces Acceptance for NDA Filing of Lower Dose Submicron Diclofenac for the Treatment of Mild to Moderate Acute Pain in Adults


3/4/2013 10:40:02 AM

PHILADELPHIA--(BUSINESS WIRE)--Iroko Pharmaceuticals, LLC, a Philadelphia-based pharmaceutical company focused on the development and commercialization of innovative therapeutic products, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lower dose submicron diclofenac, a non-steroidal anti-inflammatory drug (NSAID), with a proposed indication of treatment of mild to moderate acute pain in adults. “The FDA’s acceptance of our first NDA filing for lower dose submicron diclofenac is an important milestone for Iroko,” said John Vavricka, President and CEO of Iroko Pharmaceuticals. “Our goal is to address the significant unmet need in pain management by bringing new options to patients and physicians. We look forward to working closely with the FDA during the review process.”

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