US FDA approves Claris' anti-infective drug tobramycin injection

Claris Lifesciences Limited, which specialises in general injectables that are used in critical care environments in the hospitals, has received approval of US Food and Drug Administration (FDA) for its anti-infective drug, tobramycin injection. “The company has received the abbreviated new drug application (ANDA) approval for Tobramycin injection (80 mg/2mL and 1200 mg/30mL multiple dose vials) in the US,” said Claris Lifesciences in a press release on July 6, 2016.
 
Tobramycin injection, the estimated market size of which in the US is $ 6 million, is currently in shortage list of US FDA, the company added.
 
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.
   
With this approval, Claris now has a total of 14 approvals and 24 under approval ANDAs and the total addressable market size of the approved ANDAs is estimated to be a little above $ 300 million. The company expects more product approvals during the year, which will allow it to continue its growth in the US market.