Claris Lifesciences receives US FDA approval for flumazenil injection

The Ahmedabad-based injectable major Claris Lifesciences has received approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) of flumazenil injection USP 0.5 mg/5mL and 1 mg/10 mL multiple dose vials. Intravenous flumazenil is primarily used to treat overdoses of benzodiazepines (type of medication known as tranquilisers) and to help reverse anaesthesia.

The approval has come for the same plant where FDA had recently completed prior approval inspection, said Claris Lifesciences in a press release. The estimated market size of the approved product in the US is $ 4 million.

With this approval, the company now has a total of 16 approvals and 23 under approval ANDAs, the total addressable market size of the approved ANDAs is estimated to be about $ 300 million. 

The company expects more product approvals during the year, which will allow it to continue its growth in the US market, added Claris Lifesciences.