Navigation Links
Actavis Receives FDA Approval of Zolpidem Tartrate Extended-Release Tablets USP, 12.5 mg CIV in the U.S.
Date:6/6/2011

MORRISTOWN, N.J., June 6, 2011 /PRNewswire/ -- Actavis, an international generic pharmaceuticals company, today announced that it has received final approval from the US Food & Drug Administration to market Zolpidem Tartrate Extended-Release Tablets USP, 12.5 mg CIV.  Distribution of the product has commenced.  

Actavis was the first company to launch Zolpidem Tartrate Extended-Release Tablets 6.25 mg strength in October 2010 with 180-day exclusivity.

Zolpidem Tartrate Extended-Release Tablets, the generic equivalent of Ambien® CR , had US sales of approximately $793 million for the 12 months ending March 31, 2011, according to IMS Health.    

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

"The approval of Zolpidem ER Tablets 12.5 mg enables Actavis to offer both strengths to meet the needs of our customers.  This approval also underscores Actavis' emphasis and commitment to bringing complex controlled-release products to the marketplace to help improve patient access to pharmaceuticals."

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

About Actavis Inc.

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

Actavis Group hf 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.

Ambien® is a trademark owned by a party other than Actavis.

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
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Actavis Receives Approval of Alprazolam ODT in the U.S.
2. Actavis Launches Generic Version of Flomax(R) In The U.S.
3. Sagent Pharmaceuticals and Actavis Enter Into Exclusive U.S. Development, Supply and Marketing Collaboration for a Portfolio of Specialty Injectable Pharmaceutical Products
4. Actavis Receives Approval of Bupropion HCl SR 100mg and 200mg in the U.S.
5. Actavis Receives FDA Approval of Atomoxetine HCl Capsules
6. Actavis Receives Approval of Losartan Potassium Tablets, USP in the U.S.
7. Actavis Receives Approval of Zolpidem Tartrate Extended-Release Tablets, USP 6.25mg CIV in the U.S. with 180-Day Marketing Exclusivity
8. Actavis Inc. Issues a Voluntary Recall of 18 Lots of Fentanyl Transdermal System 25 mcg/h
9. Actavis Encourages Consumers to Return Fentanyl Transdermal System 25 mcg/h
10. Actavis Receives Approval of Pantoprazole Sodium Delayed-Release Tablets, USP in the U.S.
11. Actavis Receives Approval of Valacyclovir Hydrochloride Tablets in the U.S.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... Research and Markets has announced the addition of ... report to their offering. ... kidney failure, it replaces the function of kidneys by removing ... thus the treatment helps to keep the patient body,s electrolytes ... Increasing number of ESRD patients & substantial healthcare expenditure ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... to 2022" report to their offering. ... financial data derived from varied research sources to present unique ... on the market during the next five years, including a ... markets, regional and country level analysis. The report provides a ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 /PRNewswire/ ... Diabetes Tomorrow,s Leaders Scholarship is any indication, the future ... today online at www.diabetesscholars.org by the Diabetes ... stand in the way of academic and community service ... scholarship program since 2012, and continues to advocate for ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... industry today announced its strategic partnership with Connance, a healthcare industry leader ... two companies’ proven, proprietary technology combine to provide health systems, hospitals and ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice ... "Film editors can give their videos a whole new perspective by using the ... of Pixel Film Studios. , ProSlice Levels contains over 30 Different presets to ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... Austin residents ... the American College of Mohs Surgery and to Dr. Russell Peckham for medical and ... highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson ... Recently, he has implemented orthobiologic procedures as a method for treating his patients. ... the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... June 19, ... the dangers associated with chronic pain and the benefits of holistic treatments, Serenity ... who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a ...
Breaking Medicine News(10 mins):