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 t
'/>"/>

SOURCE Actavis
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

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:7/31/2014)... COLORADO SPRINGS, Colo. , July 31, 2014 ... Company specializing in cannabis formulation-based drug development and ... has commenced production of multiple strains of cannabis ... scientific research to select the best strains for ... to bring the cannabis formulations to market for ...
(Date:7/31/2014)... Texas , July 31, 2014 Vermillion, Inc. ... and women,s health, will hold a conference call on Thursday, ... results for the second quarter ended June 30, 2014. Financial ... the call. Vermillion,s Chairman, President and CEO ... question and answer period. Date: Thursday, August 14, ...
(Date:7/31/2014)... , July 31, 2014  Today, ... a new extension to its PageCenterX ® ... software is designed to provide downtime reporting capabilities ... outages. LRS is releasing the product for general ... environment, EMR applications experience outages for a variety ...
Breaking Medicine Technology:Cannabis Science Initiates Scientific Cultivation Programs to Test Multiple Strains of Cannabis to Obtain Extract Formulations for Clinical Drug Development Targeting Multiple Critical Ailments Starting with Cancer and Neurological Disorders 2Vermillion Sets Second Quarter 2014 Conference Call for Thursday, August 14, 2014 2LRS Announces Downtime Reporting Solution for Healthcare 2
... SEATTLE, WA, Nov. 13 Omeros Corporation (Nasdaq: ... and commercializing products focused on inflammation and disorders of ... hold a conference call on Thursday, November 19, 2009 ... provide a corporate update. Gregory A. Demopulos, M.D., Chairman ...
... EDDA Technology today announced the completion of ... an advanced clinical application designed to enhance efficiency ... planning. , IQQA®-Liver provides a comprehensive toolset ... liver lobes and segments, hepatic lesions, and vascular ...
Cached Medicine Technology:Omeros Corporation to Host Third Quarter 2009 Financial Results Conference Call on November 19 2EDDA Technology Completes CE Mark for IQQA(R)-Liver for Fast Quantitative Volumetry Assessment from Liver MDCT 2EDDA Technology Completes CE Mark for IQQA(R)-Liver for Fast Quantitative Volumetry Assessment from Liver MDCT 3
(Date:8/1/2014)... “When insulation goes bad,” Clean Crawls says, “It ... newly released article entitled, “ 5 Signs That Your ... ,” Clean Crawls explains the need to replace insulation ... critters. , Get a free attic insulation or ... http://www.cleancrawl.com/contact . , If crawl space or attic insulation ...
(Date:8/1/2014)... 2014 Over 20,000 entrepreneurs from around ... 2014 Market America | SHOP.COM International Convention at the ... annual event will introduce new products, technology, programs and ... and also feature a who’s who of celebrities. ... SHOP.COM Executive Team, successful entrepreneurs and celebrity guests. Previous ...
(Date:8/1/2014)... CA (PRWEB) August 01, 2014 ... advancing gynecologic endoscopic surgery, is pleased to announce ... in the United States and Europe, which strongly ... available to surgeons an endoscopic dry lab for ... of their endoscopic surgery skills. , Endoscopy is ...
(Date:8/1/2014)... 01, 2014 Stress management can be difficult ... hours of concentration and diminish rest and leisure time, stress ... is critical to find a way to manage stress in ... life. , “Having a good sense of work-life balance is ... Jacobs, founding clinician of SF Custom Chiropractic. “Stress, left ...
(Date:7/31/2014)... July 31, 2014 The 2013 ... developments about chemical listings, appellate decisions, litigation and ... may affect compliance with California's Proposition 65. , ... the law, regulations, history and trends impacting California's ... fourth installment of the series which adds approximately ...
Breaking Medicine News(10 mins):Health News:5 Signs That Insulation Should Be Replaced Detailed in a Newly Released Article By Clean Crawls 2Health News:Market America | SHOP.COM Set to Unveil Technology Enhancements and New Products at the 2014 International Convention 2Health News:Market America | SHOP.COM Set to Unveil Technology Enhancements and New Products at the 2014 International Convention 3Health News:Market America | SHOP.COM Set to Unveil Technology Enhancements and New Products at the 2014 International Convention 4Health News:Market America | SHOP.COM Set to Unveil Technology Enhancements and New Products at the 2014 International Convention 5Health News:AAGL Announces It Has Joined With Other Medical Societies to Encourage Hospitals Teaching Endoscopic Surgery to Establish Simulator Labs for Training 2Health News:SF Custom Chiropractic Celebrates National Relaxation Day and the Benefits of Massage Therapy for the Month of August 2Health News:Save 25% on the Proposition 65 Handbook - 2013 Edition Through August 31 2
... marketing is a missed opportunity for states to improve ... alcohol advertising laws from the Center on Alcohol Marketing ... of Public Health. The report examines the ... different best practices to reduce youth exposure to alcohol ...
... of an important clinical trial on age-related macular degeneration ... (or CATT), were published in the journal Ophthalmology ... Avastin (bevacizumab) and Lucentis (ranibizumab), commonly used to treat ... maintaining vision. In this clinical trial ...
... -- A management plan to gather, assess and respond to ... approved until they are no longer on the market is ... an Institute of Medicine report released Tuesday. The U.S. ... trial evidence that their benefits outweigh their risks. However, the ...
... MONDAY, April 30 (HealthDay News) -- A new analysis ... says those with a family history of breast cancer or ... The benefits of getting a mammogram every two years ... increased risk for developing breast cancer, according to the U.S. ...
... 1 (HealthDay News) -- Taser guns used by law enforcement ... according to a new study. Tasers, which are widely ... countries, are designed to stun suspects by delivering a 50,000-volt ... analyzed the cases of eight healthy men, ages 16 to ...
... for ordering chest CT examinations translates into positive examinations ... The study, conducted at Massachusetts General Hospital in Boston, ... of a decision support system, found that 76% of ... , "Rising concerns about radiation risks, imaging growth and ...
Cached Medicine News:Health News:Majority of states fail to address youth exposure to alcohol marketing 2Health News:Interpreting the Avastin-Lucentis study for persons with macular degeneration 2Health News:Interpreting the Avastin-Lucentis study for persons with macular degeneration 3Health News:Better Ways Needed to Track Drug Safety: Report 2Health News:Better Ways Needed to Track Drug Safety: Report 3Health News:Here Are the Women Who Need Mammograms in Their 40s: Study 2Health News:Here Are the Women Who Need Mammograms in Their 40s: Study 3
Smartepil II is a laser particularly indicated for hair-removal where it has proved to be a valid instrument, even in the treatment of darker phototypes and telangiectasias of the face and legs....
... Tri-Active is the result of ... the combination of three different methods ... to your skin. This treatment is ... of cellulite through the combined action ...
... is a CO2 laser system with ... Its functions in continuous and super-pulsed ... extreme laser intervention delicacy. Excellent as ... it comes with a large LCD ...
... professional digital imaging system for ophthalmology and ... to acquire, analyze, and store your patient ... use the most are,available right on the ... easily. This high-resolution system supports images captured ...
Medicine Products: