New Delhi, Aug. 4
Ranbaxy Laboratories Ltd announced on Friday that it has received tentative approval from the US Food and Drug Administration (USFDA) to manufacture and market Risperidone oral solution (1 mg/mL).
Risperdal (risperidone) is indicated for the treatment of schizophrenia.
The total annual market sales for risperidone oral solution were at $66 million. "We are pleased to receive this tentative approval for Risperidone oral solution.
This product represents a future opportunity for Ranbaxy and will be launched following final approval from the USFDA," Mr Jim Meehan, Vice-President of Sales and Marketing for Ranbaxy Pharmaceuticals Inc, said.
Ranbaxy Pharmaceuticals Inc is a wholly owned subsidiary of Ranbaxy Laboratories Ltd. It is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.