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Panacea Biotec gets USFDA’s approval for Rizatriptan Benzoate Tablet

18 Jan 2017 Evaluate

Panacea Biotec has received approval from US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) to market a generic version of Rizatriptan Benzoate Tablet, Orally Disintegrating, 5 mg and 10 mg.

This generic is equivalent to MAXALT-MLT ODT of Merck & Co. The current annual sales for Rizatriptan Benzoate Tablet, Orally Disintegrating, 5 mg and 10 mg in the US market is around $ 60 million. Rizatriptan Benzoate is a serotonin (5-HT) 1B/11) receptor against (triptan) indicated for the acute treatment of migraine in adults and in pediatric patients.

Further, the company is planning to launch the product within first quarter of 2017 through its distribution partner in US. Recently, the company got approval of its anti-cancer formulation facility from USFDA in November, 2016.

Panacea Biotec is one of the India’s leading research based health management companies with established research, manufacturing and marketing capabilities.
 


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