Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market Rizatriptan Benzoate tablets 5mg (base) and 10mg (base) (ANDA 202490), which was earlier tentatively approved. The product is ready for launch.
Rizatriptan Benzoate tablets 5mg (base) and 10mg (base) is the generic equivalent of Merck and Co’s Maxalt tablets 5mg (base) and 10mg (base) and is indicated for the acute treatment of migraine with or without aura in adults and in paediatric patients six to 17 years old. The annual sale of the product is approximately $300 million for the twelve months ending March 2012 according to IMS.
The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad.
Aurobindo now has a total of 171 ANDA approvals (146 final approvals including two from Aurolife Pharma and 25 tentative approvals) from US FDA.
EP News Bureau – Mumbai