US health regulator has given its nod to Jubilant Life Sciences to market its generic version of anti-migrane tablets, zolmitriptan orally disintegrating tablets, in America.
The company has received nod from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for zolmitriptan orally disintegrating tablets in strengths of 2.5 mg and 5 mg, Jubilant Life Sciences said in a regulatory filing.
The company’s drug is a generic version of AstraZeneca’s Zomig-ZMT tablets, which is used for acute treatment of migraine headaches in adults.
As on June 30, 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.
Jubilant Life Sciences shares were trading at Rs 339.35 apiece on BSE, up 2.66 per cent from previous close.