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Biovail Updates Status of NDA for Tramadol ER
...announced that it has received comments from the United States Food and Drug Administration (FDA) with regard to its New Drug Application (NDA) for Tramadol ER, an extended-release, once-daily formulation of tramadol hydrochloride. The FDA has acknowledged that Biovail's Complete Response to the Tramadol...
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FDA Accepts Labopharm's Response for Once-Daily Tramadol as Complete Class 2 Response
...2 response. The action date assigned by the FDA under the Prescription Drug User Fee Act (PDUFA) is January 2, 2009. About Labopharm's Once-Daily Tramadol Product Labopharm's once-daily tramadol product is based on the Company's proprietary Contramid(R) technology, which provides a dual matrix delivery...
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Labopharm Receives Response from FDA Regarding its Once-Daily Tramadol Product
...the U.S. Food and Drug Administration (FDA) regarding its most recent appeal of the decision in the Agency's Approvable Letter for its once-daily tramadol formulation through the Formal Dispute Resolution process. Procedurally, Dr. Douglas Throckmorton, M.D., the FDA's Deputy Director, Center for...
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Labopharm Provides Update on U.S. Regulatory Process for Once-Daily Tramadol
Company Believes Robust Clinical Data Package Provided in NDA Demonstrates Efficacy and Safety of Once-Daily Tramadol Formulation LAVAL, QC, September 24, 2007 /PRNewswire-FirstCall/ - Labopharm Inc. today announced that is has requested a meeting with the U.S....
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Labopharm Receives Second Approvable Letter from FDA for Once-Daily Tramadol
...today announced that it has received a second approvable letter from the U.S. Food and Drug Administration (FDA) for its once-daily formulation of tramadol. In the second approvable letter (dated May 30, 2007), the FDA stated that Labopharm has not demonstrated the efficacy of its once-daily formulation...
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