FDA accepts Labopharm’s response for once-daily tramadol
Specialty pharmaceutical company Labopharm Inc. (Nasdaq:DDSS) announced before the opening today that the U.S. Food and Drug Administration had accepted its response for once-daily tramadol. The company said the FDA accepted the response as being a complete, Class 2 response. The action date assigned by the FDA is Jan. 2, 2009, under the Prescription Drug User Fee Act.
Once-daily Tramadol provides rapid and sustained drug release that maintains blood levels and provides a full 24 hours of pain relief, the company said.
In today’s pre-market trading, shares of Canada-based Labopharm are flat at $1.52. During the past 52 weeks, shares have ranged from $0.63 to $3.04.
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