AstraZeneca Claims FDA Skirted Seroquel Exclusivity

Law360, New York (April 5, 2012, 6:13 PM EDT) -- AstraZeneca PLC asked a Washington federal judge on Wednesday to vacate U.S. Food and Drug Administration approval of generic versions of its antipsychotic medication Seroquel, arguing the FDA's approval violated the drug company's exclusivity rights.

AstraZeneca’s patent for Seroquel expired last week, but it claims it can continue to be the drug's sole producer until December because the FDA instructed the company in December 2009 to label packaging with a warning about hyperglycemia, or high blood sugar, and granted it rights to the clinical data behind...
To view the full article, register now.