Labopharm appeals FDA's Tramadol decision
TORONTO |
TORONTO Oct 15 (Reuters) - Labopharm Inc DDS.TO said on Monday it started a formal appeal process with the U.S. Food and Drug Administration in hopes of reversing the agency's decision on its Tramadol once-daily pain formula.
The company said it "firmly believes it has met the statutory standards for approval" of the formulation.
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