Actavis Receives Approval of Zolpidem Tartrate Extended-Release Tablets, USP 6.25mg CIV in the U.S. with 180-Day Marketing E... ( MORRISTOWN N.J. Oct. 18 /- Actavis Gr...)

HOME >> MEDICINE >> TECHNOLOGY

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
'/>"/>

SOURCE Actavis Inc.
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2
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:5/24/2013)... An international roster of experts on malignant pleural ... Santa Monica, Calif. , to discuss their ... a rare form of cancer that results from exposure ... of the chest. Hosted by UCLA and ... Annual International Symposium on Lung-Sparing Therapies for Malignant Pleural ...

(Date:5/24/2013)... YORK , May 24, 2013 In accordance ... Rules and Rule 14e-1 of the United States Exchange Act, ... its original offer for Elan Corporation (NYSE: ELN). ... Limited ("Royalty Pharma") made an offer for the entire of ... Corporation, plc ("Elan") (the "Original Offer"). On ...

(Date:5/23/2013)... , May 24, 2013 3SBio Inc. ... "Company"), a leading China -based ... marketing biopharmaceutical products, announced today that, at an ... Company,s shareholders voted in favor of the proposal ... and plan of merger dated February 8, 2013, ...

Breaking Medicine Technology:International Mesothelioma Experts Present Promising New Research Findings at the 3rd Annual International Symposium on Lung-Sparing Therapies for Malignant Pleural Mesothelioma 2 International Mesothelioma Experts Present Promising New Research Findings at the 3rd Annual International Symposium on Lung-Sparing Therapies for Malignant Pleural Mesothelioma 3 Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 2 Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 3 Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 4 Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 5 Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 6 Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 7 Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 8 Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 9 3SBio Inc. Announces Shareholders' Approval of the Amended Merger Agreement 2 3SBio Inc. Announces Shareholders' Approval of the Amended Merger Agreement 3

[0] International Mesothelioma Experts Present Promising New Research Findings at the 3rd Annual International Symposium on Lung-Sparing Therapies for Malignant Pleural Mesothelioma [0] Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements [0] 3SBio Inc. Announces Shareholders' Approval of the Amended Merger Agreement

... CHENGDU, China, Jan. 7, 2011 /PRNewswire-Asia-FirstCall/ -- Tianyin ... ), a pharmaceutical company that specializes in patented ... other pharmaceuticals today announced that the Company,s 2010 ... New York Stock Exchange Conference Room 632 on Monday, ...

... 2011 Athersys, Inc. (Nasdaq: ATHX ) today ... present at Retail Investor Confrences.com. DATE: , January 11, ... will be a live, interactive online event where investors are ... the presentation hall as well as the company,s "virtual trade ...

Cached Medicine Technology:Tianyin Pharmaceutical to Hold 2010 Shareholder Annual Meeting on March 21, 2011 at NYSE 2 Athersys to Present Live at Retail Investor Conferences.com on January 11th 2

Tianyin Pharmaceutical to Hold 2010 Shareholder Annual Meeting on March 21, 2011 at NYSE Athersys to Present Live at Retail Investor Conferences.com on January 11th

(Date:5/25/2013)... BC (PRWEB) May 25, 2013 According ... the most beautiful and powerful women that ever lived. ... felt by some of the most powerful men in ... many beauty remedies to keep her skin glowing and ... made with bees- wax, maringa oil and cyprus grass. ...

(Date:5/25/2013)... May 25, 2013 For college ... finals week. Increasingly, they are turning to prescription ... and study. For more on this, go to ... treatment facility, warns that students who pick up ... at risk for developing a physical and psychological ...

(Date:5/25/2013)... May 25, 2013 HealthCrave Medical ... is unique in that it doesn’t just focus ... on treating what causes the noticeable signs of ... Dr. James D. Weiss, M.D., the center provides ... process while helping patients to live longer, healthier ...

(Date:5/24/2013)... A recent study by research group Harris ... upcoming bathing suit season. Almost 138 million people are fearful ... due to weight issues and a quarter admit they feel ... Labs recommends that those anxious about their size consider the ... of an overall effort to improve diet and exercise habits ...

(Date:5/24/2013)... 24, 2013 Compromise is often cited as ... it comes to sleep and comfort. However, many couples find ... individual. For some, this can cause added stress, lost sleep, ... blog, tackles eight common issues in their latest article on ... He Wants Firm: What to do When You Disagree on ...

Breaking Medicine News(10 mins):Health News:The Cleopatra Lift - A New Non Surgical Option to Aging Offered by Vancouver Physician 2 Health News:The Cleopatra Lift - A New Non Surgical Option to Aging Offered by Vancouver Physician 3 Health News:Addiction and Drug Abuse: Study Drug Adderall Abuse Spikes During Finals 2 Health News:Anti-Aging Center Offers Advanced Treatment that Controls the Aging Process from Within 2 Health News:PhenObestin 37.5 Can Help Make Bathing Suit Season Less Stressful 2 Health News:PhenObestin 37.5 Can Help Make Bathing Suit Season Less Stressful 3 Health News:What’s The Best Bed Offers Mattress & Sleep Solutions for Opposite Couples 2

[0] The Cleopatra Lift - A New Non Surgical Option to Aging Offered by Vancouver Physician [0] Addiction and Drug Abuse: Study Drug Adderall Abuse Spikes During Finals [0] Anti-Aging Center Offers Advanced Treatment that Controls the Aging Process from Within [0] PhenObestin 37.5 Can Help Make Bathing Suit Season Less Stressful [0] What’s The Best Bed Offers Mattress & Sleep Solutions for Opposite Couples

... Weight Watchers program and obesity training, state,s,largest Medicaid managed ... Association to provide medical professionals the opportunity to ... in conducting Breathe Well, Live Well program, CHARLESTON, ... among the highest in the country in asthma prevalence,UniCare ...

... and HONOLULU, March 12 Allscripts,the leading ... that physicians use to improve healthcare, today ... that provides,technology and support services to more ... statewide license for the Allscripts Electronic Health,Record ...

... in 30% of middle schoolers studied, blamed on acids ... News) -- Dental erosion -- the loss of the ... the United States, researchers say. , "This study is ... prevalence of dental erosion in this country and, more ...

... March 12 As part of its ongoing ... decision-making,Independence Blue Cross today announced that four area ... Complex and Rare Cancers(SM)., Blue Distinction(R) is ... to make wise health care decisions and to ...

... Campaign Features "Superheroes" Theme, WASHINGTON, March 12 ... Agency for Healthcare Research and Quality,(AHRQ) joined with ... public service campaign designed to encourage,Hispanics to become ... urges,Hispanics to stay healthy for their loved ones ...

... TORONTO, March 12 /PRNewswire-FirstCall/ - Bradmer ... the development and,commercialization of cancer therapies, today ... operational and financial results., Operational Highlights, ... 2007, the Company achieved the,following steps in ...

UniCare of West Virginia Providing Assistance for Asthma Education Training Hawaii's Premier Physician Management Company, TeamPraxis, Selects Allscripts Electronic Health Record for Statewide Deployment Dental Erosion on Rise in U.S.Independence Blue Cross Announces Blue Distinction Centers for Complex and Rare Cancers(SM) in Philadelphia AHRQ and Ad Council Encourage Hispanics to Become More Involved in Their Health Care Bradmer announces 2007 fourth quarter and fiscal year operational and financial results

Inquire...

Glucose tubes contain an anti-coagulant and a stabiliser. The tubes are ideal for glucose and lactate determinations....

BD Vacutainer® Fluoride Tubes - Glass...

VACUETTE Trace Element tubes - Ridged (safety screw cap) are designed to test trace elements such as Cu, Zn, Pb, etc....

Medicine Products:

MONOJECT Grey Stopper VACUETTE Glucose tubes - Non-ridged (pull cap)BD Vacutainer® Fluoride (Glucose) Tubes - Glass VACUETTE Trace Element tubes - Ridged (safety screw cap)