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Aurobindo Pharma receives final USFDA nod for Risperidone syrup

Posted on: September 7, 2009 at 5:33 pm | 80 views




Aurobindo Pharma is pleased to announce that it has received the final approval for Risperidone oral solution 1mg/ml from the US Food and Drug Administration (USFDA).

Risperidone oral solution 1mg / ml is generic equivalent to Risperdal oral solution 1mg/ml of Ortho-McNeil Janssen.

Risperidone oral solution is indicated in the treatment schizophrenia and falls under the neurological (CNS) segment. This product has a market of approximately USD 68 million for the twelve months ending March 2009 according to Newport. The product will be launched shortly.

Aurobindo now has a total of 102 ANDA approvals (74 final approvals and 28 tentative approvals) from USFDA.





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