Lannett's (LCI) Memantine Hydrochloride Tabs ANDA Approved by U.S. FDA
- Unemployment Rate Drops to 4.6%
- Unusual 11 Mid-Day Movers 12/2: (ASNA) (HTBX) (REPH) Higher; (PLX) (MEMP) (DRYS) Lower
- Bond yields fall on U.S. jobs data, euro flat before Italy vote
- Alibaba (BABA) Founder Jack Ma Discuss Plans to Retire; 'I Don't Want to Die at the Office'
- Starbucks Coffee (SBUX) CEO Howard Schultz to Step Down, Appointed Executive Chairman; Kevin Johnson New CEO
Get daily under-the-radar research with StreetInsider.com's Stealth Growth Insider Get your 2-Wk Free Trial here.
Lannett Company, Inc. (NYSE: LCI) announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg, the therapeutic equivalent to the reference listed drug, Namenda Tablets, 5 mg and 10 mg, of Forest Laboratories LLC. According to IMS, total U.S. sales in 2015 of Memantine Hydrochloride Tablets USP, 5 mg and 10 mg, at Average Wholesale Price (AWP) were approximately $50 million.
"Memantine Hydrochloride Tablets is indicated for the treatment of moderate to severe dementia," said Arthur Bedrosian, chief executive officer of Lannett. "This product is in addition to our Memantine Oral Solution and represents the ninth product approval we have received in calendar 2016. We expect to commence marketing the product in approximately two months."
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Lannett (LCI) Receives FDA Extension on Methylphenidate Hydrochloride ER Tabs Document Submission
- Shire's (SHPG) Phase 3 Investigational Study of VONVENDI Meets Primary Endpoint in Controlling Bleeding in Adults with VWD
- PICO Holdings (PICO) Announces Leadership, Governance Changes; Terminates Central Square Agreement
Create E-mail Alert Related CategoriesCorporate News, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!