Navigation Links
Mylan Announces Tentative FDA Approval for Generic Version of Antihypertensive Avalide(R) Tablets
Date:6/16/2008

PITTSBURGH, June 16 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Irbesartan and Hydrochlorothiazide Tablets, 150 mg/12.5 mg and 300 mg/12.5 mg.

Irbesartan and Hydrochlorothiazide Tablets, indicated for the treatment of hypertension, are the generic version of Sanofi Aventis' Avalide(R) Tablets, which had U.S. sales of approximately $288 million for the 12 months ending March 31, 2008, according to IMS Health.

Currently, Mylan has 92 ANDAs pending FDA approval, 20 of which are potential first-to-file opportunities.

Mylan Inc., with a presence in more than 90 countries, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest -- and highest quality -- product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.


'/>"/>
SOURCE Mylan Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1

Related medicine news :

1. Mylan Commences Tender Offers and Consent Solicitations for Its 5.750% Senior Notes Due 2010 and 6.375% Senior Notes Due 2015 in Connection With Its Proposed Acquisition of Mercks Generic Pharmaceutical Business
2. Mylan Announces Final FDA Approval for Carvedilol Tablets
3. Mylan Announces Tentative FDA Approval for Topiramate Capsules
4. Mylan Announces Appointment of M. Fabiana Lacerca as Senior Vice President and Chief Compliance Officer
5. Mylan Announces Extension of Tender Offers for Its 5.750% Senior Notes due 2010 and 6.375% Senior Notes due 2015
6. Mylan Announces Appointment of David A. Lillback as Senior Vice President and Global Head of Human Resources
7. Mylan Announces Appointment of Brian Byala as Senior Vice President and Treasurer
8. Mylan Announces Appointment of Didier Barret as President, Europe, Middle East and Africa
9. Mylan Announces Appointment of Harry A. Korman as President, North America
10. Mylan Announces Appointment of John Montgomery as President, Asia Pacific
11. Mylan Announces Management of Specialty Business, Dey L.P.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/24/2017)... ... January 24, 2017 , ... “Choosing Wisdom-Solomon’s ... finances, friendship, marriage, leadership, gossip, prostitution, adultery, anger, and common sense. , ... Judith Coats and Dr. David Coats. In September of 1983, they flew to ...
(Date:1/24/2017)... ... January 24, 2017 , ... “The Octagon of Spiritual Balances”: a ... Balances” is the creation of published author, Pastor Bernard J. Weathers, pastor of Word ... bachelor degree in religious education and a master degree in theology. , ““The Octagon ...
(Date:1/24/2017)... Arlington, Va. (PRWEB) , ... January 23, 2017 ... ... (H.R. 592) was reintroduced on Friday, January 20, with the bipartisan original co-sponsorship ... 109) was re-introduced on January 12. The National Association of Chain Drug Stores ...
(Date:1/24/2017)... ... January 23, 2017 , ... ... Texas with the acquisitions of two personal care service companies: Padre Home Health ... Texas, effective January 1, 2017. , Well regarded in their respective markets, these ...
(Date:1/24/2017)... ... 24, 2017 , ... The National Council of Alcoholism and Drug Dependence ( ... worked with communities to designate the last full week of January as National Drug ... “Shatter the Myths.” As a community, we can advocate for effective treatment, but ...
Breaking Medicine News(10 mins):
(Date:1/24/2017)... 23, 2017 ArisGlobal, a leading ... announces agClinical 3.3, the latest version of its comprehensive ... science organizations to confidently and efficiently meet new compliance ... the electronic trial master file so that compliance is ... ...
(Date:1/23/2017)... , Jan. 23, 2017 Endo International ... Trade Commission (FTC) today filed a joint motion in ... California seeking the entry of ... Order resolves all disputes between the FTC and Endo ... in connection with its Opana® ER and Lidoderm® products.  ...
(Date:1/23/2017)... CLARA, Calif. , Jan. 23, 2017 /PRNewswire/ ... protection market, Frost & Sullivan recognizes Ansell, a ... Global Frost & Sullivan Company of the Year ... customer-centric approach, and a wide global footprint have ... in the hand protection market. The Company,s established ...
Breaking Medicine Technology: