Claris Lifesciences and its subsidiaries has received an Abbreviated New Drug Application (ANDA) approval for Flumazenil Injection USP, 0.5mg/SmL and 1mg/10mL multiple dose vials, in the United States of America. The ANDA approval has come for the same plant where the FDA had recently completed their Prior Approval Inspection (PAI).
The estimated market size 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 a little above $300 million.
The company is expecting more product approvals during the year, which will allow it to continue its growth in the US market.
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