Claris Gets US Regulator's Nod For Anti-Bacterial Infections Injection

New Delhi: Drug firm Claris Lifesciences has received approval from the US Food and Drug Administration (FDA) for a generic injection used in treatment of bacterial infections in the American market.

"The company has received abbreviated new drug application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Tobramycin injection USP, 80mg/2mL and 1200mg/30mL multiple dose vials," Claris Lifesciences said in a filing to the BSE.

The estimated market size of the product in the US is $6 million. The product is currently in the US health regulator's shortage list, it added.

With this approval, the company has a total of 14 approvals and 24 under approval ANDAs and is expecting more product approvals during the year, Claris Lifesciences said.

Injection Tobramycin is an anti-infective used to treat certain serious infections that are caused by bacteria.