Ryzolt Approval History
Marketing Status: Discontinued
Ryzolt (tramadol extended release) is a once-daily analgesic indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
Development History and FDA Approval Process for Ryzolt
|Dec 31, 2008||Labopharm Announces FDA Approval of Once-Daily Ryzolt for Moderate to Moderately Severe Chronic Pain|
|Jul 17, 2008||FDA Accepts Labopharm's Response for Once-Daily Tramadol asComplete Class 2 Response|
|Jul 3, 2008||Labopharm Submits Complete Response to FDA as a Result of Outcomeof Appeal Process for Once-Daily Tramadol|
|Jun 30, 2008||Labopharm Receives Response from FDA Regarding its Once-DailyTramadol Product|
|Apr 1, 2008||Labopharm Appeals FDA's Decision on Once-Daily Tramadol to NextSupervisory Level After Additional Analysis Supports Efficacy|
|Jan 24, 2008||Labopharm Receives FDA Response to Recent Appeal of ApprovableLetter For Once-Daily Tramadol|
|Oct 15, 2007||Labopharm Appeals FDA's Decision on Once-Daily Tramadol|
|Sep 25, 2007||Labopharm Provides Update on U.S. Regulatory Process for Once-DailyTramadol|
|Jun 29, 2007||Labopharm Meets with FDA to Discuss Second Approvable Letter forOnce-daily Tramadol|
|Jun 1, 2007||Labopharm Receives Second Approvable Letter from FDA for Once-DailyTramadol|
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