Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for Bosutinib Tablets, 100 mg and 500 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bosulif Tablets, 100 mg and 500 mg, of PF Prism C.V. (PF Prism).
Bosutinib tablets are indicated for the treatment of a certain type of leukemia called Philadelphia chromosome-positive chronic myelogenous leukemia.
Bosutinib Tablets, 100 mg and 500 mg have an estimated market size of US$ 275 million for twelve months ending March 2024 according to IQVIA. Alembic has a cumulative total of 206 ANDA approvals (179 final approvals and 27 tentative approvals) from USFDA.
Powered by Capital Market - Live News
Disclaimer: No Business Standard Journalist was involved in creation of this content
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 →
Smart Quarterly
₹900
3 Months
₹300/Month
Smart Essential
₹2,700
1 Year
₹225/Month
Super Saver
₹3,900
2 Years
₹162/Month
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