FDA nod for Jubilant's generic drug for migraine
September 21, 2015 | Monday | News | By BioSpectrum Bureau
FDA nod for Jubilant's generic drug for migraine
The drug is the generic version of Zomig-ZM of Astra Zeneca
Jubilant Life Sciences has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Zolmitriptan Orally Disintegrating Tablets, 2.5 mg and 5 mg. The drug is the generic version of Zomig-ZMT(of Astra Zeneca), which is used for acute treatment of migraine headaches in adults.
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.
