 "Lupin receives US FDA approval for generic Suprep bowel prep kit")
Lupin Ltd has received final approval for its sodium sulfate, potassium sulfate, and magnesium sulfate oral solution, 17.5 g/3.13 g/1.6 g per 6 ounces, from the US Food and Drug Administration (FDA) to market a generic version of Braintree Laboratories’ Suprep bowel prep kit.
According to Lupin, it is eligible for 180 days of generic drug exclusivity for the approved product, which indicated for cleansing of the colon in preparation for colonoscopy in adults. As per IMS (MAT December 2016), Suprep bowel prep kit had US sales of $ 207.2 million.
Meanwhile, Lupin Limited has also received final approval for its oxycodone & acetaminophen tablet (2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg) from the US drug regulator. The approved product is a generic version of Vintage Pharmaceuticals’ Percocet tablet, which is indicated for relief of moderate to moderately severe pain. According to IMS Health, Percocet tablet recorded annual US sales of $ 838.7 million in 2016.
One subscription. Two world-class reads.
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%