Drug firm Jubilant Life Sciences has received final approval from the US health regulator for generic Levetiracetam injection, used for treatment of epilepsy, in the American market.
The company has received abbreviated new drug application (ANDA) final approval for Levetiracetam injection USP, 500 mg/5 mL (100 mg/mL) from the United States Food and Drug Administration (USFDA), Jubilant Life Sciences said in a BSE filing.
The company’s product is the generic version of UCB’s Keppra injection in the same strength, it added.
“As on March 31, 2016, Jubilant Life Sciences had a total of 739 filings for formulations, of which 517 have been approved in various regions globally. This includes 72 ANDAs filed in the US, of which 44 have been approved and 46 Dossier filings in Europe,” the company said.
Shares of Jubilant Life Sciences today closed 1.42 per cent down at Rs 352.95 on BSE.