Claris gets USFDA nod for generic anti-bacterial infections injection
New Delhi : Drug firm Claris Lifesciences has received approval from the US health regulator for generic Tobramycin injection used for the 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 BSE.
The estimated market size of the product in the US is USD 6 million. The product is currently in shortage list of USFDA, 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.
Tobramycin injection is an anti-infective used to treat certain serious infections that are caused by bacteria.