Aurobindo pharma secures USFDA approval from anti-migraine tablets
The drug firm gets USFDA nod for the Rizatriptan Benzoate Tablets used in the treatment of migraine.
Hyderabad, January 1, 2013: Aurobindo Pharma has received the final approval from US Food and Drug Administration (USFDA) to manufacture and market Rizatriptan Benzoate Tablets used in the treatment of migraine.
The company said in a statement that the product which was earliest tentatively approved by the USFDA is now ready for launch. It is worth mentioning here that the Rizatriptan Benzoate Tablets 5mg (base) and 10mg (base) is the generic equivalent of Merck and Co's Maxalt Tablets of equivalent dose and is used in the treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
As per the IMS data, annual sale of the product is worth approximately US$ 300 million for 12 months ending March 2012. With this approval Aurobindo Pharma now have a total of 171 abbreviated new drug application (ANDA) approvals (146 Final approvals including two from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA.