Aurobindo Pharma gets USFDA’s approval for Rizatriptan Benzoate Tablets

02 Jul 2013 Evaluate

Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Rizatriptan Benzoate Orally Disintegrating Tablets (ODT) 5mg and 10mg. The Abbreviated New Drug Application (ANDA) 203062 is ready for launch.

Rizatriptan Benzoate ODT 5mg and 10mg are the generic equivalent of Merck & Co. Inc’s Maxalt-MLT ODT 5mg and 10mg respectively and indicated for the acute treatment of migraine in adults and in pediatric patients 6 to 17 years of age.

The annual sale of the product is about $271 million for 12 months ending April 2013 as per IMS. The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India.

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

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