FDA Delays Decision On Roche Anemia Drug

Law360, New York (December 15, 2006, 12:00 AM EST) -- U.S. regulators have accepted Roche Holding AG’s Biologic License Application for its hotly litigated anti-anemia drug Mircera, but will extend their review for another three months to review extra data submitted by the company.

Roche announced Friday that the U.S. Food and Drug Administration granted it a three-month extension of the review period for Mircera, which is at the center of a patent infringement suit filed by Amgen Inc. in Boston on Nov. 8, 2005.

Eduard Holdener, Roche’s Global Head for Pharma Development, painted the submission...
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