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Approval for Labopharm's Tramadol seen by January Thu Jul 17, 2008 3:28pm EDT Email | Print | Share| Reprints | Single Page| Recommend (0) [-] Text [+] Related News Pfizer argues against epilepsy drug warning 10 Jul 2008 TransCanada’s Maine wind farm wins state approval 09 Jul 2008 FDA changing notices on drug decisions 09 Jul 2008 powered by Sphere Market News Wall St rallies on oil below $130, earnings hopes Microsoft shares fall after earnings miss Google earnings miss expectations, shares drop More Business & Investing News... Featured Broker sponsored link Learn to Trade with a FREE Guide.TORONTO (Reuters) - Labopharm Inc (DDS.TO: Quote, Profile, Research, Stock Buzz) inched closer to U.S. approval of the once-daily version of its Tramadol pain treatment on Thursday, after the Food and Drug Administration accepted the analysis provided by the Canadian drug company. Labopharm's shares were up 6 Canadian cents, or 4 percent, at C$1.57 late Thursday afternoon after climbing as high as C$1.83 earlier in the session. Labopharm said acceptance of the data should lead to an FDA decision on the approval of once-daily Tramadol for use in the United States by January 2, 2009. Late last month, the FDA suggested the company submit a previously requested analysis of the drug and said that a positive finding using this analysis could support the efficacy of the product, which could lead to regulatory approval. The company received notification from the FDA in May 2007 that its Tramadol treatment would not be approved until certain conditions were met. The drawn-out approval process has been costly for Labopharm and its development partner, Purdue Pharma LLP. The company expected FDA approval in September 2006, and had prepared for a U.S. launch in both 2006 and mid-2007. By not receiving FDA approval during this quarter, it stands to lose a $10 million milestone payment agreed to with Purdue, Versant Partners analyst Doug Loe said in a note. Loe sees Labopharm filing a new drug application in the third quarter of this year, with regulatory approval in the first quarter of 2009. Labopharm's once-daily version of Tramadol has been launched in 11 countries, including Canada, and is approved in 19 others. (Reporting by Scott Anderson; editing by Rob Wilson) |
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| aus der Diskussion: | Labopharm ....Nur geschenkt ist noch billiger |
| Autor (Datum des Eintrages): | Bombenleger (17.07.08 23:51:38) |
| Beitrag: | 19 von 324 (ID:34534036) |
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