Iroko Pharmaceuticals Announces First International Filing for ZORVOLEX®
7/8/2014 6:59:46 AM
PHILADELPHIA--(BUSINESS WIRE)--Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced the company affiliate’s first regulatory submission outside of the United States for ZORVOLEX® (diclofenac) capsules. A new drug application was filed for the nonsteroidal anti-inflammatory drug (NSAID) with the Republic of Lebanon Ministry of Public Health (MOPH). ZORVOLEX was approved by the U.S. Food and Drug Administration (FDA) in October 2013 for the treatment of mild to moderate acute pain in adults and is not currently approved for marketing in any other country. A supplemental New Drug Application seeking approval for osteoarthritis pain is currently being reviewed by FDA.
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