Laboratorios Farmaceúticos Rovi’s Risvan (risperidone) once-monthly injectable, a proposed 505(b)(2) hybrid version of Janssen-Cilag’s Risperdal tablets, has been handed a new US Food and Drug Administration user fee goal date after the Spanish player submitted final responses to a second complete response letter denying its approval.
But as it continues to push through Risvan, Rovi has confirmed that Teva is not in consideration
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