(Reuters) - Labopharm said it received a second approvable letter from
the U.S. Food and Drug Administration, signaling the medicine
would not be approved until certain conditions are met. The
company said it was possible the agency would require
additional data before the drug could be approved.
The FDA said Labopharm had not demonstrated the efficacy of
its once-daily formulation of tramadol because statistical
methods used to analyze data from clinical trials did not
adequately address missing data relating to those who dropped
out and did not complete the study, the company said.
Read more at Reuters.com Government Filings News
the U.S. Food and Drug Administration, signaling the medicine
would not be approved until certain conditions are met. The
company said it was possible the agency would require
additional data before the drug could be approved.
The FDA said Labopharm had not demonstrated the efficacy of
its once-daily formulation of tramadol because statistical
methods used to analyze data from clinical trials did not
adequately address missing data relating to those who dropped
out and did not complete the study, the company said.
Read more at Reuters.com Government Filings News
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