Claris Lifesciences Ltd has announced that it has received the abbreviated new drug application (ANDA) approval for Tobramycin injection USP, 80mg/2mL and 1200 mg/30mL multiple dose vials, in the United States of America.
The estimated market size in the US is USD 6 million and the product is currently in shortage list of US Food & Drug Administration.
With this, Claris now has a total of 14 approvals and 24 under approval ANDAs.
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, lungs, skin, bones, joints and urinary tract.