 "Alembic arm receives final USFDA approval for generic fever blisters drug")
Alembic Pharmaceuticals on Wednesday said its wholly-owned arm Aleor Dermaceuticals has received final approval from the US health regulator for its generic Docosanol cream indicated for cold sore/fever blisters on the face or lips.
The final approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Docosanol cream, 10 per cent (over the counter), the company said in a regulatory filing.
The approved ANDA is therapeutically equivalent to the reference listed drug product Abreva Cream, 10 per cent (OTC) of GlaxoSmithKline Consumer Healthcare, it added.
Citing IQVIA data, Alembic said Docosanol cream, 10 per cent (OTC) has an estimated market size of USD 60 million for 12 months ending December 2021.
Alembic has received a cumulative total of 166 ANDA approvals (142 final approvals and 24 tentative approvals) from the USFDA, it added.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
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