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Cipher Provides Product Update on Cip-Isotretinoin and Cip-Tramadol ER
...our belief that our product could represent an advance in the treatment of severe acne. We expect to meet with the FDA in late January 2008.' Cip-Tramadol ER In December 2007, Cipher announced that it had appealed the position taken by the FDA in its approvable letter for the Company's extended-release...
New Drug Applications (FDA) · More like this

Labopharm Reports Results for Phase III Study on Twice-daily Tramadol-acetaminophen Formulation
...- Labopharm Inc. today announced the results of its recently completed North American Phase III clinical trial for its twice-daily formulation of tramadol and acetaminophen (study 06CCL3-001). Study 06CCL3-001 was a multi-centre, randomized, double-blind, parallel-arm study that compared the efficacy...
Clinical Trial Results (FDA) · More like this

Labopharm Meets with FDA to Discuss Second Approvable Letter for Once-daily Tramadol
...Drug Administration (FDA) to discuss the matters raised in the Agency's May 30, 2007 Approvable Letter for the Company's once-daily formulation of tramadol. The Company believes that the meeting with the Agency was productive and that the statistical analysis required by the FDA to achieve approval...
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Labopharm Appeals FDA's Decision on Once-Daily Tramadol to Next Supervisory Level After Additional Analysis Supports Efficacy
...- Labopharm Inc. today announced that it has appealed the U.S. Food and Drug Administration's (FDA) decision on its once-daily tramadol formulation to the next supervisory level under the FDA's Formal Dispute Resolution process. Labopharm's continuation of the appeal process follows...
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Labopharm Appeals FDA's Decision on Once-Daily Tramadol
...and Drug Administration (FDA)'s Formal Dispute Resolution process, appealing the Agency's decision regarding the Company's once-daily formulation of tramadol. Labopharm received a second Approvable Letter from the FDA for its once-daily formulation of tramadol in May of this year. The Company firmly...
New Drug Applications (FDA) · More like this

See also: Fibromyalgia, Pain, Restless Legs Syndrome, Vulvodynia

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