Reuters

FDA to rule on Labopharm's Tramadol by January

Thu Jul 17, 8:48 AM

TORONTO (Reuters) - The U.S. Food and Drug Administration has accepted the analysis Canadian drug company Labopharm Inc has provided on its once-daily version of the pain treatment Tramadol in response to FDA requests, the company said on Thursday.

Labopharm said the acceptance of the data should lead to an FDA decision on approval of its Tramadol product for use in the United States by January 2, 2009.

Late last month, the FDA suggested that the company submit a previously requested analysis of the drug and said that a positive finding using this analysis could support the efficacy of the product, which could lead to regulatory approval.

The company received notification from the FDA in May 2007 that its Tramadol treatment would not be approved until certain conditions were met.

The drawn-out approval process has been costly for Labopharm and its development partner, Purdue Pharma LLP. The company expected FDA approval in September 2006, and had prepared for its U.S. launch in both 2006 and mid-2007.

Labopharm's once daily version of Tramadol has been launched in 11 countries, including Canada, and is approved in 19 others.

(Reporting by Scott Anderson; Editing by Peter Galloway)

LIKE IT?  LET OTHERS KNOW

Be the first to recommend - Sign in now


See what other people are recommending - Popular Stories