Labopharm Inc., of Laval, Québec, Canada, has announced that it has received approval for Ryzolt (tramadol HCl extended-release tablets) in a once-daily formulation.
The analgesic is indicated for management of moderate to moderately severe chronic pain in adult patients who require around-the-clock pain treatment for an extended period.
“The approval of our first product in the United States is a major milestone for our company, and we look forward to the launch of our product by our marketing partner for the United States, Purdue Pharma,” said James R. Howard-Tripp, Labopharm’s president and chief executive officer.
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The launch of Ryzolt tablets in 100-mg, 200-mg, and 300-mg dosage strengths is expected in the second quarter of this year.
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