Canadian firm Labopharm said Tuesday the U.S. Food and Drug Administration accepted it response to matters the agency raised regarding tramadol. Chempharm, which did not, disclosed what it is response contained, said the FDA set an action date of June 19, 2007, for it is once-daily formulation of tramadol.
The U.S. Food Drug Administration (FDA) gives rights to all the companies to market their drug, but what the organization says about these products during various stages of review can move stocks enormously, and particularly if the drug in question can or will make up a significant portion of a company's business.
The following discussion with the Food Drug Administration, Labopharm submitted its response to the matter raised in the approval letter for once-daily tramadol on December 19, 2006." The company said in statement.
The Food Drug Administration sent Labopharm an approval letter lats September in response to the new drug application the company filed for tramadol in November 2005. The FDA decision, while not a guarantee of full approval of the drug in the future, is a step in the right direction, according to Albert Paul. As a result, he has hiked his price target on Labopharm with a market neutral rating.
But the fact is that the Food Drug Administration awarded Labopharm a six month review period of the company's re-submission, rather than a possible two months, seems to have disappointed the market. Tramadol could see U.S. commercial launch late this year, at which point it will face competition from major brand names such as Johnson & Johnson.
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