Shire: FDA extends review period for Mesavance

By Lisa Kerner

Charlotte, N.C., Sept. 8 - The Food and Drug Administration extended the review period for Shire plc's New Drug Application for Mesavance by 90 days.

The extension gives the agency additional time to review supplemental phase 1 data, according to Shire, a London-based specialty pharmaceutical company.

The company said it anticipates that Mesavance will be approved and launched in the United States and Europe during the first quarter of 2007.

The new action date for the application is Jan. 21, 2007.

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