Jubilant Life Sciences gets USFDA’s nod for Rizatriptan Benzoate Orally Disintegrating Tablets

20 Oct 2015 Evaluate

Jubilant Life Sciences 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, the company 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.

Jubilant Life Sciences is an integrated global Pharmaceutical and Life Sciences Company engaged in manufacture and supply of APIs, Solid Dosage Formulations, Specialty Pharmaceuticals and Life Science Ingredients.

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