Pharmabiz
 

Aurobindo receives US FDA and Swissmedic approvals

Our Bureau, MumbaiMonday, September 7, 2009, 08:00 Hrs  [IST]

Aurobindo Pharma has received US FDA final approval for Risperidone oral solution 1mg/ml. The product is generic equivalent to Risperidal oral solution 1mg/ml of Ortho-McNeil Janssen. It is indicated in the treatment of schizophrenia and falls under the neurological segment. The product has a market size of approximately US$ 68 million for the twelve months ending March 2009 according to Newport. The company is going to launch this product in short time. Similarly, Aurobindo has also received two approvals from Swissmedic, Government of Switzerland for the license of amlodipine APL 5 mg and 10 mg tablets and metformin APL 500 mg, 850 mg and 1000 mg tablets. Amlodipine APL tablets falls under the cardio vascular disorder therapeutic segment and is indicated for the treatment of angina pectoris and of mild to moderate hypertension, alone or in combination with other anti-hypertensives. Metformin APL tablets is a biguanide anti-diabetic and indicated as an adjunct to diet and exercise to improve glycaemic control in adults and children with type-2 diabetes mellitus. With these approvals, Aurobindo has four products approvals from Swissmedic and 102 ANDA from US FDA.

 
[Close]