Jubilant Life Sciences Ltd 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 tablets of Merck. Rizatriptan benzoate orally disintegrating tablet 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.
