Aurobindo Pharma has received the final approval for its Risperidone Oral Solution 1mg/mL from the US Food and Drug Administration (USFDA).
Risperidone Oral Solution is the generic equivalent to Risperdal Oral Solution of Ortho-McNeil Janssen. It is indicated in the treatment schizophrenia and falls under the neurological (CNS) segment.
The product has a market size of approximately $68 million for the twelve months ending March 2009 according to Newport. The product will be launched shortly, said a press release from the company.
Aurobindo now has a total of 102 ANDA approvals (74 final and 28 tentative) from USFDA.
The company also received two approvals from Swissmedic, the Switzerland government agency, for its Amlodipine APL (5mg and 10mg) tablets and Melformin APL (500mg, 850mg and 1,000mg) tablets.
Amlodipine is indicated for hypertension with other drug combinations. Melformin is indicated for diabetes mellitus (type 2).
Aurobindo has now received four approvals from Swissmedic.