Navigation Links
Mylan Receives Final FDA Approvals for Generic Versions of Lamictal(R) Tablets and Lamictal(R) CD
Date:1/28/2009

PITTSBURGH, Jan. 28 /PRNewswire-FirstCall/ --Mylan Inc. (Nasdaq: MYL) today announced that its subsidiaries Mylan Pharmaceuticals Inc. and Genpharm ULC received final approvals from the U.S. Food and Drug Administration (FDA) for their Abbreviated New Drug Applications (ANDAs) for Lamotrigine Tablets. Genpharm also received final FDA approval for its ANDA for a separate Lamotrigine product, Lamotrigine Tablets Chewable Dispersible (CD).

Mylan Pharmaceuticals' and Genpharm's ANDAs were approved for the 25 mg, 100 mg, 150 mg and 200 mg strengths of the generic version of GlaxoSmithKline's Lamictal(R) Tablets. This product had annual U.S. sales of approximately $2.5 billion for the 12 months ending Sept. 30, 2008, for the same strengths according to IMS Health.

Genpharm's ANDA was approved for the 5 mg and 25 mg strengths of the generic version of GlaxoSmithKline's Lamictal(R) CD Tablets. This product had annual U.S. sales of approximately $91 million for the 12 months ending Sept. 30, 2008, for the same strengths according to IMS Health.

These products are used for the treatment of epilepsy and for maintenance treatment of bipolar I disorder. Mylan will distribute both products immediately and under the Mylan Pharmaceuticals label.

Mylan Inc., which provides products to customers in more than 140 countries and territories, 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 third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.


'/>"/>
SOURCE Mylan Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Mylan Receives Final FDA Approval for Generic Version of Prilosec(R) Delayed-Release Capsules, 40 mg
2. U.S. Patent and Trademark Office Issues Mylans Specialty Division, Dey L.P., Three Additional Patents Protecting Perforomist(R) Inhalation Solution
3. Mylan to Present at the 27th Annual J.P. Morgan Healthcare Conference
4. Mylans Matrix Receives Final FDA Approval for the Generic Version of the Antiretroviral Zerit(R) Capsules
5. Mylan Announces Move to NASDAQ Stock Market
6. Mylan Announces Settlement Agreement with Novartis Related to Femara(R) First- to-File Opportunity
7. Mylan Receives Final FDA Approval for the Generic Version of the Antidepressant Sarafem(R) Pulvules(R) Capsules
8. Mylan Receives Final Approval for First-to-File Generic Version of Antiepileptic Keppra(R) and Launches Immediately
9. Mylan Declares Quarterly Preferred Stock Dividend
10. Mylans Matrix First-to-File on Generic Version of Vfend(R) Antifungal
11. Mylan to Retain Dey, L.P., Its Specialty Pharmaceutical Subsidiary
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/20/2017)... ... September 20, 2017 , ... “Psalms of Humidity”: is a ... mind and move the readers one step closer to God. “Psalms of Humidity” is ... his mistakes that have been made within his life are the very same things ...
(Date:9/20/2017)... ... ... “They Sang At Her Funeral”: a tale of murder that will bring ... their closets. “They Sang At Her Funeral” is the creation of published author, Annalise ... five children and twelve grandchildren. Before becoming a writer, Annalise had the opportunity to ...
(Date:9/19/2017)... ... 19, 2017 , ... Only a few physicians were selected to receive the ... A. Clevens, MD, FACS . The founder and medical director of Clevens Face ... trained at Yale, Harvard and the University of Michigan. He has served patients throughout ...
(Date:9/19/2017)... ... , ... Trusted debt-reduction firm CreditAssociates, LLC has announced two important milestones. To ... $835 million in resolved debt for its clients. , Credit card debt, unpaid hospital ... of debt settled by the company. With more than a decade of combined service ...
(Date:9/19/2017)... Dallas, TX (PRWEB) , ... September 19, 2017 ... ... largest non-profit organization devoted exclusively to funding innovative lymphoma research and serving the ... services – will return to Texas as a part of its national Swirl: ...
Breaking Medicine News(10 mins):
(Date:9/19/2017)... 19, 2017 HistoSonics, Inc., a venture-backed medical device company developing a non-invasive, robotically ... announced three leadership team developments today:   ... ... Tom ... Veteran medical device executive Josh Stopek , PhD, who ...
(Date:9/19/2017)... --  ZirMed Inc ., a recognized leader in cloud-based revenue ... been ranked #1 by its users for the seventh consecutive ... Survey. ZirMed was recognized as the top-ranked end-to-end revenue cycle ... over 200 beds and holds one of the longest #1 ... ...
(Date:9/18/2017)... , Pa. and KALAMAZOO, Mich. , ... Allentown, Penn. , and OptiMed Specialty Pharmacy of ... business partnership to offer a strategic hub service that ... Healthcare,s highly sought-after personal spirometer, Spiro PD 2.0, and ... A spirometer is a medical device used to ...
Breaking Medicine Technology: