FDA has confirmed 3-years exclusivity for Tramadol ER

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October 2005

FDA has confirmed 3-years exclusivity for Tramadol ER

Canadian drugmaker Biovail Corporation (NYSE,TSE:BVF) said Friday that the United States Food and Drug Administration (FDA) has confirmed 3-years of exclusivity for its once-a-day painkiller Tramadol ER (tramadol hydrochloride). Tramadol ER will have 100mg, 200mg and 300mg dosage strengths and will arrive early in 2006.

Friday's announcement came less than two months after the company said it had won final approval plus three years of exclusive market access from the FDA.

Biovail rivals Labopharm Inc. and Cipher Pharmaceuticals are also developing their own versions of Tramadol.

Cipher Pharmaceuticals Inc. is an innovative pharmaceutical development company.

Labopharm Inc. is an international, specialty pharmaceutical company

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