Drug maker Aurobindo Pharma Ltd today said it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Rizatriptan Benzoate Tablets used in the treatment of migraine.
The product which was tentatively approved by the FDA earlier, is ready for launch, a statement from Aurobindo said.
Rizatriptan Benzoate Tablets 5mg (base) and 10mg (base) is the generic equivalent of Merck and Co's Maxalt Tablets of equivalent dose and is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
The annual sale of the product is approximately $300 million for 12 months ending March 2012 according to IMS data, the release said.
The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad.
Aurobindo now has a total of 171 abbreviated new drug application (ANDA) approvals (146 Final approvals including 2 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA, according to Aurobindo.
Aurobindo scrip is traded at Rs 193.25 apiece on BSE in the afternoon trade.