Roxane Receives FDA Approval For Risperidone Oral Solution

FDA has approved Roxane’s Abbreviated New Drug Application (ANDA) for its Risperidone Oral Solution, 1mg/mL.

Risperidone 1 mg/ml oral solution is indicated for the treatment of schizophrenia. Risperidone is effective as maintenance therapy for the prevention of relapse in chronic schizophrenic patients, who have shown an initial treatment response with risperidone.

Roxane’s Risperidone oral solution, 1mg/mL are AA rated to RISPERDAL (risperidone) oral solution. Annual sales of Risperidone is approximately $69.6 million, said the company.

Roxane is a subsidiary of Boehringer Ingelheim, which markets over 80 medications in nearly 250 package sizes. It focuses on an expanding line of Multisource pharmaceutical products including: bulk and unit-dose liquids and solids, coated, sustained-release and controlled-release tablets, nasal sprays, cytotoxics, and CII narcotics.