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:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on the ... announced that patient enrollment in its ongoing randomized ... has exceeded 50% of its 24-patient target. Capricor ... the third quarter of 2016, and to report ...
(Date:6/23/2016)... BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a ... second affiliate in Latin America . ... ... ... ...
(Date:6/23/2016)... , June 23, 2016  Experian ... integrating and transforming the patient payment and ... several innovative new products and services that ... its revenue cycle offerings. These award-winning solutions ... efficient workflows, remain compliant in an ever-changing ...
Breaking Medicine Technology:
(Date:6/24/2016)... , ... June 24, 2016 , ... People across the ... Genome magazine’s Code Talker Award, an essay contest in which patients and their families ... to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & ... (TGIG), has initiated cultivation and processing operations at its production facility, and opened ... , Puradigm is the manufacturer of a complete system of proactive air and ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) sponsors ... on June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, ... to helping service members that have been wounded in battle and their families. Venture ...
(Date:6/24/2016)... ... June 24, 2016 , ... Finally, a bruise cream that ... dermaka cream can be incorporated into the post-surgical treatment plans of a variety of ... , dermaka cream is very effective for bruising and causes a rapid resolution of ...
(Date:6/24/2016)... New York (PRWEB) , ... June 24, 2016 , ... ... marijuana patients optimize the ingestion of their medication by matching users with high quality ... users to compare pieces with no commitment. , Inhale was founded by two brothers, ...
Breaking Medicine News(10 mins):