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news.Iroko Pharmaceuticals, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, has announced that the company affiliate’s first regulatory submission outside of the United States for ZORVOLEX (diclofenac) capsules.
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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.
"The first ZORVOLEX filing outside of the United States is a tremendous milestone for our company, building on a very busy first half of 2014, which included the ZORVOLEX U.S. launch, FDA approval of our second low dose NSAID and receipt of critical patents for both products," said John Vavricka, President and CEO of Iroko Pharmaceuticals.
This filing was the result of a licensing agreement signed late last year by the company’s affiliate, Iroko Pharmaceuticals Inc., and Algorithm S.A.L. under which Algorithm obtained the exclusive rights to market and sell ZORVOLEX to countries in the Middle East and North Africa (MENA).
"We are pleased with this first milestone to come from our partnership with Iroko and look forward to bringing this low dose NSAID option to patients and prescribers throughout the MENA region," said Selim Ghorayeb, CEO of Algorithm.
Iroko will continue to retain all marketing rights to ZORVOLEX in the United States, and is in discussions with additional companies to bring ZORVOLEX to other international markets. ZORVOLEX has been available in U.S. pharmacies since January of this year, and has since seen continuing growth in prescriptions.
"We are delighted to see the first fruits of our partnership with Algorithm and are looking forward to expanding access to ZORVOLEX and eventually, other products from our low dose SoluMatrix NSAID portfolio, across the MENA region and the rest of the world," said Osagie Imasogie, Executive Chairman of the Board, Iroko Pharmaceuticals.