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Jubilant Life Sciences receives ANDA final approval for Levetiracetam Injection

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From USFDA

Jubilant Life Sciences has received Abbreviated New Drug Application (ANDA) final approval for Levetiracetam Injection USP, 500 mg/5 mL (100 mg/mL), the generic version of Keppra Injection 500mg/5mL (100mg/mL) of UCB, which is used for the treatment of epilepsy.

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.

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First Published: Jun 03 2016 | 7:53 PM IST

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