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

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

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:
(Date:6/26/2016)... One of Australia,s successful biotechnology scientists, Dr ... biotechnology company, Noxopharm Limited [ABN 50 608 966 123] ("Noxopharm"). Noxopharm ... on the ASX. Noxopharm is a clinic-ready company with ... 1 clinical study later this year. ... problems facing cancer patients - the ability of cancers to become ...
(Date:6/26/2016)... DUBLIN , June 27, 2016 Jazz ... the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act ... proposed acquisition of Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: ... 11:59 p.m. (Eastern Daylight Time). As previously ... entered into a definitive merger agreement under which Jazz ...
(Date:6/26/2016)... -- VMS Rehab Systems, Inc. ( ) reported today ... to build a strong and stable market for trading ... the OTC Markets-pink current trading platform. Explains ... seeing an anomaly in market trading activities that may ... Company, but shareholders and market players as well. I ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ePAY ... partnership with Connance, a healthcare industry leader providing predictive analytics to optimize ... combine to provide health systems, hospitals and ambulatory surgical centers with dramatic ...
(Date:6/27/2016)... ... June 27, 2016 , ... recently awarded their highest five-star rating to ... of individuals in the United States and Canada wear eyeglasses. Once considered to be ... vision and make a fashion statement. Even celebrities use glasses as a way of ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, ... the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, where ... city’s history as home to some of the world’s leading providers of cereal and ...
(Date:6/26/2016)... , ... June 26, 2016 , ... PawPaws brand ... new product that was developed to enhance the health of felines. The formula is ... The two main herbs in the PawPaws Cat Kidney Support Supplement Soft ...
(Date:6/26/2016)... Michigan (PRWEB) , ... June 26, 2016 , ... ... to fertility once they have been diagnosed with endometriosis. These women need a ... they also require a comprehensive approach that can help for preservation of fertility ...
Breaking Medicine News(10 mins):