Rovi Is Weeks From Long-Acting Risperidone Filing
Long-Acting Letrozole Injectable At Phase I Stage
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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Spain’s Laboratorios Farmaceuticos Rovi has set out why it remains confident in its prospects for its Becat (enoxaparin) biosimilar to Sanofi’s Lovenox/Clexane while providing an update for the firm’s Doria once-a-month injectable formulation of risperidone.
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.
Germany’s off-patent industry association, Pro Generika, is finding ample support for its position that by awarding tender contracts to exclusive suppliers, health insurance funds are contributing to drug shortages in the country.