City-based Claris Lifesciences Ltd informed that the company has received the Abbreviated New Drug Application (ANDA) approval for Tobramycin Injection USP, 80mg/2mL and 1,200mg/30mL multiple dose vials, in the US.
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 estimated market size in the US is $6 million, as the product is currently in shortage list of the US dug regulator, US Food and Drug Administration (USFDA).
With this approval, Claris now has 14 approvals and 24 under approval ANDAs. The total addressable market size of approved ANDAs is estimated to be a little above $300 million, the company claimed in a statement.
Claris expects more product approvals during the year, which will allow it to continue its growth in the US market, it said.