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Ryzolt Approval History

  • FDA approved: Yes (First approved December 30th, 2008)
  • Brand name: Ryzolt
  • Generic name: tramadol
  • Dosage form: Extended Release Tablets
  • Company: Labopharm Inc.
  • Treatment for: Pain

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

DateArticle
Dec 31, 2008Approval Labopharm Announces FDA Approval of Once-Daily Ryzolt for Moderate to Moderately Severe Chronic Pain
Jul 17, 2008FDA Accepts Labopharm's Response for Once-Daily Tramadol as Complete Class 2 Response
Jul  3, 2008Labopharm Submits Complete Response to FDA as a Result of Outcome of Appeal Process for Once-Daily Tramadol
Jun 30, 2008Labopharm Receives Response from FDA Regarding its Once-Daily Tramadol Product
Apr  1, 2008Labopharm Appeals FDA's Decision on Once-Daily Tramadol to Next Supervisory Level After Additional Analysis Supports Efficacy
Jan 24, 2008Labopharm Receives FDA Response to Recent Appeal of Approvable Letter For Once-Daily Tramadol
Oct 15, 2007Labopharm Appeals FDA's Decision on Once-Daily Tramadol
Sep 25, 2007Labopharm Provides Update on U.S. Regulatory Process for Once-Daily Tramadol
Jun 29, 2007Labopharm Meets with FDA to Discuss Second Approvable Letter for Once-daily Tramadol
Jun  1, 2007Labopharm Receives Second Approvable Letter from FDA for Once-Daily Tramadol

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