Claris bags US approval for anti-infections injection

Claris Lifesciences Limited on Wednesday said it has received an Abbreviated New Drug Application (ANDA) approval in the United States for an injection used in the treatment of a host of infections.

The Tobramycin injection USP, available in 80mg/2mL and 1200mg/30mL multiple dose vials, is used to treat serious infections caused by bacteria leading to meningitis and other infections of the blood, abdomen (stomach area), lungs, skin, bones, joints and the urinary tract.

The estimated market size of the product in the US is $6 million dollars and is currently in shortage list of the US Food and Drugs Administration.

Claris Lifesciences Limited along with its subsidiaries is a leading sterile injectables company specialising in general injectables used in critical care environments in hospitals across the world.

According to a company release here, with this approval Claris now has a total of 14 approvals and 24 under-approval ANDAs. The total addressable market size of the approved ANDAs is estimated to be a little above $300 million dollars.

The firm hopes for more product approvals during the year, which will allow it to continue its growth in the US market.

--IANS

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