Labopharm Inc. today announced that it has submitted a complete response to the Food and Drug Administration (FDA) per the suggestion of Dr. Douglas Throckmorton, M.D., the FDA's Deputy Director, Center for Drug Evaluation and Research (CDER), as the next step in the regulatory path towards potential U.S. approval of the Company's once-daily formulation of tramadol. The complete response centers on the additional analysis of existing data using the methodology put forward by Dr. John K. Jenkins, M.D., Director for the Office of New Drugs, CDER, in his letter earlier this year.
The details can be read here.
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