Tuesday, August 26, 2008

Biovail gets expanded Canadian approval for Ralivia

TORONTO, Aug 25 (Reuters) - Biovail Corp (BVF.TO: Quote, Profile, Research, Stock Buzz) (BVF.N: Quote, Profile, Research, Stock Buzz) said on Monday it received approval for an expanded indication for once-daily Ralivia, a pain management drug given for adults who need continuous treatment for several days or more.

The Therapeutic Products Directorate in Canada, the federal authority that regulates pharmaceutical drugs and medical devices for human use, approved the expansion of the indication for treatment of moderately severe pain, which is in addition to the drug being given for moderate pain.

The new indication is based on the results of four, 12-week trials with Ralivia in more than 3,000 patients with persistent, moderate-to-severe pain due to osteoarthritis of the knee and/or hip, and low back pain.

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