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FDA clears Aurobindo’s Rizatriptan Benzoate orally disintegrating tablets

India-based Aurobindo Pharma has obtained final FDA approvals to manufacture and market Rizatriptan Benzoate orally disintegrating tablets (ODT) 5mg and 10mg (ANDA 203062).

Set for launch, Rizatriptan Benzoate ODT 5mg and 10mg are the generic equivalent of Merck’s Maxalt-MLT ODT 5mg and 10mg respectively.

Approved out of Unit VII (SEZ) formulations facility in Hyderabad, India, the product is indicated for the acute treatment of migraine in adults and in pediatric patients six to 17 years of age.

The annual sale for 12 months ending April 2013 of the product was approximately $271m, according to IMS data.

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients with product portfolio spread over antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals, and anti-allergics.