Navigation Links
Actavis Receives Approval of Zolpidem Tartrate Extended-Release Tablets, USP 6.25mg CIV in the U.S. with 180-Day Marketing Exclusivity
Date:10/18/2010

MORRISTOWN, N.J., Oct. 18 /PRNewswire/ -- Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the US Food & Drug Administration to market Zolpidem Tartrate Extended-Release Tablets, USP 6.25mg CIV.  Distribution of the product has commenced.

As the first company to file an ANDA that contained a paragraph IV certification for Ambien® CR 6.25mg, Actavis has been awarded 180-day exclusivity to market this product.

Zolpidem Tartrate Extended-Release Tablets 6.25mg, the generic equivalent of Ambien® CR 6.25mg by Sanofi-Aventis, had US sales of approximately $129 million for the 12 months ending June 30, 2010, according to IMS Health.

Commenting on the new approval, Doug Boothe, CEO of Actavis in the US, said:

"The approval of Zolpidem ER Tablets 6.25mg offers a significant value to our customers and patients.  This approval, along with the first-to-file exclusivity, also underscores Actavis' emphasis and commitment to bringing complex controlled-release products to the marketplace."

Please see prescribing information at www.actavis.us/Zolpidem.

About Actavis Inc.

Actavis Inc. is the US subsidiary of Actavis Group hf. Approximately one third of Actavis' sales are generated in North America, Actavis' single largest market.  Based in Morristown, NJ, Actavis has US manufacturing facilities in Elizabeth, NJ and Lincolnton, NC.  Actavis also has research and development facilities in Owings Mills, MD and Sunrise, FL.

About Actavis Group

Actavis is one of the world's leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals.  The company has operations in 40 countries, with more than 10,500 employees.

Information in this press release may contain forward-looking statements with respect to the financial condition, results of operations and businesses of Actavis.  By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future.  There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements.  These factors include, among other things, exchange rate fluctuations, the risk that research and development will not yield new products that achieve commercial success, the impact of competition, price controls and price reductions, the risk of loss or expiration of patents or trade marks, difficulties of obtaining and maintaining governmental approvals for products, the risk of substantial product liability claims, exposure to environmental liability.


'/>"/>
SOURCE Actavis Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Actavis Receives Approval of Losartan Potassium Tablets, USP in the U.S.
2. Actavis Receives FDA Approval of Atomoxetine HCl Capsules
3. Actavis Receives Approval of Bupropion HCl SR 100mg and 200mg in the U.S.
4. Sagent Pharmaceuticals and Actavis Enter Into Exclusive U.S. Development, Supply and Marketing Collaboration for a Portfolio of Specialty Injectable Pharmaceutical Products
5. Actavis Launches Generic Version of Flomax(R) In The U.S.
6. Actavis Receives Approval of Alprazolam ODT in the U.S.
7. ISTA Pharmaceuticals Receives FDA Approval for BROMDAY™
8. Watsons Generic Version of Lotrel ® Receives FDA Approval
9. EntreMed Receives Notice of NASDAQ Compliance
10. Mylan Receives Approvals for Generic Versions of Hyzaar® and Cozaar®
11. Greenways PrimeSUITE Receives ONC-ATCB 2011/2012 Certification
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/19/2017)... , June 19, 2017  Researchers from DRUGSCAN ... that they will host a live, complimentary webinar titled, ... the benchtop to the real world" on Wednesday June ... This webinar will feature interviews with ... look into the manipulation techniques abusers use to prepare ...
(Date:6/14/2017)... June 14, 2017 The Bio Supply Management ... City of Fremont and the Biomedical Manufacturing ... industry in California by providing ... networking, and fostering workforce development. The primary focus of ... of start-ups, as well as small and mid-sized biomedical ...
(Date:6/11/2017)... June 10, 2017  Eli Lilly and Company (NYSE: ... Phase 3 studies of galcanezumab, an investigational treatment for ... data on several key secondary endpoints for galcanezumab compared ... these studies (EVOLVE-1, EVOLVE-2 and REGAIN) will be presented ... meeting in Boston . ...
Breaking Medicine Technology:
(Date:6/23/2017)... ... , ... Goodcents Deli Fresh Subs today announced the opening of a new ... St. Topeka, Kan. 66604 (near 21st and Gage). It is owned and operated by ... locations in the Topeka and Bonner Springs, Kan. area. , “Goodcents has such ...
(Date:6/23/2017)... ... June 23, 2017 , ... 21 Middle East and ... has selected 21 leaders from government, business and civil society in 11 countries across ... U.S. this fall, engaging in a transformative exchange of knowledge and ideas with the ...
(Date:6/23/2017)... ... , ... American Farmer, will feature Chr. Hansen, Inc (CHR Hansen) in an ... 2017. American Farmer airs Tuesdays at 8:30aET on RFD-TV. Check your local listings for ... Denmark in 1874 after a groundbreaking discovery of how to industrialize enzymes. Rooted in ...
(Date:6/23/2017)... TX (PRWEB) , ... June 23, 2017 , ... All-Star ... to residential and business clients throughout eastern Texas, is announcing the launch of a ... , Recent breast cancer statistics in the United States reveal that an estimated 252, ...
(Date:6/22/2017)... ... 22, 2017 , ... Plastic Surgery Associates is proud to report that founding ... year, research and information firm, Castle Connolly, releases their list of the most notable ... the 3rd time that Dr. Canales has been recognized by Castle Connolly. ...
Breaking Medicine News(10 mins):