Rovi Prioritizes Risperidone Filing In Europe Over US
Spain’s Rovi is prioritizing European filing and filling preparations for its long-acting risperidone injectable, pushing back a prospective US regulatory submission until next year.
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Rovi hopes by the end of this year to file a hybrid marketing authorization application in Europe for a once-a-month sustained-release injectable formulation of risperidone. A US filing is scheduled for the first half of next year.
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