 "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.
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.
You’ve reached your limit of {{free_limit}} free articles this month.
Subscribe now for unlimited access.
Already subscribed? Log in
Subscribe to read the full story →*Subscribe to Business Standard digital and get complimentary access to The New York Times
Smart Quarterly
₹900
3 Months
₹300/Month
SAVE 25%
Smart Essential
₹2,700
1 Year
₹225/Month
SAVE 46%
*Complimentary New York Times access for the 2nd year will be given after 12 months
Super Saver
₹3,900
2 Years
₹162/Month
Subscribe
Renews automatically, cancel anytime
Here’s what’s included in our digital subscription plans
Exclusive premium stories online
Over 30 premium stories daily, handpicked by our editors
Complimentary Access to The New York Times
News, Games, Cooking, Audio, Wirecutter & The Athletic
Business Standard Epaper
Digital replica of our daily newspaper — with options to read, save, and share
Curated Newsletters
Insights on markets, finance, politics, tech, and more delivered to your inbox
Market Analysis & Investment Insights
In-depth market analysis & insights with access to The Smart Investor
Archives
Repository of articles and publications dating back to 1997
Ad-free Reading
Uninterrupted reading experience with no advertisements
Seamless Access Across All Devices
Access Business Standard across devices — mobile, tablet, or PC, via web or app
SAVE 25%