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:2/8/2016)...  Labvantage Lx, a newcomer to the dietary ... enhancement product, EnduramenT. Setting a new standard in ... patented biomedical breakthrough molecule that promotes the controlled ... for many biological functions including erectile function. ... the use of prescription medications, scientists working on ...
(Date:2/8/2016)... and FAIRFIELD, N.J. , Feb. ... Medimetriks Pharmaceuticals, Inc. (Medimetriks) today announced that they have ... and commercialization rights for OPA-15406 in the U.S. and ... provides manufacturing rights.  OPA-15406 is a topical, non-steroidal phosphodiesterase ... dermatitis. --> --> ...
(Date:2/8/2016)... , Feb. 8, 2016  Ventana Medical ... that hundreds of the world,s top oncologists, pathologists, ... at the 12 th annual Tucson Symposium ... evolving theories and new outcomes in cancer research ... patients, lives. Thomas Grogan , annually ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... 2016 , ... The Valentine’s Season is famous for gift giving with flowers, chocolates and other ... loved. This year, for more than 5.6 million Americans suffering with Alzheimer’s, those store ... to remind them of the lives they’ve led and the people they’ve touched. ...
(Date:2/8/2016)... ... February 08, 2016 , ... Steve Helwig & Associates Insurance & ... community enrichment program, has teamed up with Citizens Opposed to Domestic Abuse in support ... abuse. To support all those victimized by the fear of violence in their own ...
(Date:2/8/2016)... ... February 08, 2016 , ... Remember the old saying “rub some dirt on ... A~, author of “Calcium Bentonite Clay” the health benefits of integrating clay into a ... the body. , A former motivational speaker, Perry A~ has since dedicated her life ...
(Date:2/8/2016)... , ... February 08, 2016 , ... ... to share this important news! AHCC and the Home Health and Hospice ICD-10 ... CMS' designee for official ICD coding guidance and clarifications, to address concerns over ...
(Date:2/8/2016)... ... ... According to research by the National Association of Dental ... certified or obtain continuing education. To increase patient awareness of the lack of ... to inform dentists and patients about the possible lack of skills and knowledge ...
Breaking Medicine News(10 mins):