Aurobindo Pharma Limited, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, has received final approvals from the US Food and Drug Administration (US FDA) to manufacture and market Rizatriptan Bezoate orally disintegrating tablets (ODT) in 5 mg and 10 mg strengths.
Rizatriptan Bezoate ODT, the generic equivalent of Merck and Co Inc’s Maxalt MLT, is indicated for the acute treatment of migraine in adults and in pediatric patients of 6-17 years of age.
The product, which is ready for launch, has been approved out of Aurobindo’s Unit-VII formulations plant in Hyderabad, the company said in a filing to the BSE on Tuesday.
According to IMS Health, an information, services and technology provider for the global healthcare industry, the annual sale of the product is approximately $271 million for the 12 months ending April 2013.
Aurobindo Pharma’s scrip is currently trading at Rs 187.10 on the BSE, up 0.11%, over the previous close of Rs 186.90 per share.
Meanwhile, pharmaceutical and bulk chemicals manufacturer Natco Pharma Limited, also from Hyderabad, today announced the receipt of a marketing approval for Rizatriptan Benzoate ODT from the US FDA.
“The company has already commenced shipments of the product, which is being launched by its marketing partner Breckenridge Pharmaceuticals,” Natco informed the BSE.