Claris get nod for Tobramycin injection is the US

Ahmedabad-based sterile injectables company Claris Lifesciences Limited along with its subsidiaries today announced that Claris has received the abbreviated new drug application (ANDA) approval for Tobramycin injection in the US.

Claris has received the nod for Tobramycin injection in the strengths of 80mg/2mL and 1200mg/30mL multiple dose vials. Tobramycin Injection is an anti-infective used to treat certain serious infections that are caused by bacteria such as meningitis and other infections of the blood, abdomen (stomach area), lungs, skin, bones, joints, and urinary tract.

The company specialises in general injectables that are used in critical care environments in the hospitals in the US and across the globe.

The estimated market size in the US is $6 million, the product is currently in shortage list of USFDA, a company statement here claimed.

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