Aurobindo Pharma gets USFDA final nod for migraine tablets

NEW DELHI: Aurobindo Pharma today said it has received final approval from the US health regulator to manufacture and market Rizatriptan Benzoate orally disintegrating tablets used for treating migraine.

The product is ready for launch in the American market, it added.

The company has received final approvals from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Rizatriptan Benzoate orally disintegrating tablets in the strengths of 5mg and 10mg, Aurobindo Pharma said in a statement.

Products are the generic equivalent of Merck & Co Inc's Maxalt-MLT orally disintegrating tablets in the same strengths and indicated for the acute treatment of migraine in adults and in paediatric patients aged 6-17 years, it added.

"The annual sale of the product is approximately USD 271 million for 12 months ending April 2013 as per IMS," Aurobindo Pharma said.

The product has been approved out of the company's formulations facility in Hyderabad, it added.

The company has a total of 192 ANDA approvals (164 final approvals, including 4 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.

Shares of Aurobindo Pharma were today trading at Rs 187.25 apiece on the BSE in afternoon trade, up 0.19 per cent from their previous close.