NEW DELHI: Jubilant Life Sciences today announced receipt of approval from the US health regulator for its generic version of Merck’s acute migraine treatment medicine, Maxalt-MLT.
The company has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (USFDA) for Rizatriptan Benzoate orally-disintegrating tablets, 5 mg and 10 mg, the company said in a BSE filing.
The medicine is 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 paediatric patients, it added.
As of 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, the company said.