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Actelion, Ltd.
Regulatory review process for bosentan in final stage in Japan
December 7th, 2004
Actelion, Ltd., (ATLN) announced that the Japanese Health Authority (MHLW) has informed the company that the regulatory review process for bosentan (Tracleer) in pulmonary arterial hypertension has entered into the final stage. Actelion has submitted revised documentation, including detailed information on the planned post-marketing surveillance program adapted to the Japanese market. No formal timelines for the review process have been given. The MHLW indicated that the bosentan orphan drug application would be reviewed with high priority, but that the dossier would not be tabled at the upcoming review meeting scheduled in late November 2004. ...
Source: Cardiovascular Business Week (2004-12-07)
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