AstraZeneca neurology news
AstraZeneca filed suit in the U.S. District Court for the District of Columbia seeking to delay FDA approval of generic versions of psychiatric drugs Seroquel quetiapine and Seroquel XR by almost nine months. The suit follows news earlier this month that FDA denied a Citizen Petition from the pharma asking the agency to withhold approval of any generic quetiapine product that omits labeling language on hyperglycemia and suicidality warnings.
Last July, the agency updated the label of Seroquel XR to warn about the risk of QT prolongation when given in combination with other drugs that are known to prolong QT. AstraZeneca said clinical data supporting the hyperglycemia warning is protected by marketing exclusivity periods that expire as late as Dec. 2. The patent covering quetiapine expired last September, while the pediatric exclusivity period expires on March 26 (see BioCentury, Aug. 1, 2011 & Oct. 10, 2011). ...