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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By the end of this year, Rovi expects to have filed in Europe for long-acting risperidone • Source: Shutterstock

Laboratorios Farmaceuticos Rovi says it is weeks away from submitting its Doria once-a-month injectable formulation of risperidone via the European Union’s hybrid Article 10(3) pathway. A US filing for the schizophrenia treatment through the 505(b)(2) pathway is scheduled for the first half of 2020.

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