Claris Lifesciences gets USFDA nod for Flumazenil injection

Monday, Aug 29, 2016

Drug firm Claris Lifesciences has received approval from the US health regulator for generic Flumazenil injection used for reversal of the sedative effects of benzodiazepines in the America market.

The company has received abbreviated new drug approval from the United States Food and Drug Administration (USFDA) for Flumazenil injection USP 0.5 mg/5mL and 1 mg/10 mL multiple dose vials, Claris Lifesciences said in a BSE filing.

The approval has come for the same plant where FDA had recently completed prior approval inspection, it added.

"With this approval the company now has a total of 16 approvals and 23 under approval ANDAs" , Claris Lifesciences said.

The firm expects more product approvals during the year.


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