Jubilant Life Sciences receives ANDA approval for Rizatriptan Benzoate OD tablets
20 October 2015 | News | By BioSpectrum Bureau
Jubilant Life Sciences receives ANDA approval for Rizatriptan Benzoate OD tablets
Jubilant Life Sciences Ltd, an integrated global Pharmaceuticals and Life Sciences Company, has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Rizatriptan Benzoate Orally Disintegrating Tablets, 5 mg and 10 mg.
The generic version of Maxalt-MLT Orally Disintegrating, 5 mg and 10 mg Tablets (of Merck), which is indicated for the acute treatment of migraine in adults and in pediatric patients.
As on June 30, 2015, Jubilant Life Sciences had a total of 815 filings for formulations of which 389 have been approved in various regions globally. This includes 72 ANDAs filed in the US, of which 38 have been approved and 46 Dossier filings in Europe.
