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).
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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.
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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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