Navigation Links
Mylan Receives FDA Approval for First-to-File Generic Depakote(R) ER
Date:1/30/2009

Company will have 180 days of marketing exclusivity on the 500 mg strength

PITTSBURGH, Jan. 30 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Divalproex Sodium Extended-release (Divalproex ER) Tablets, 250 mg and 500 mg.

Mylan has been awarded 180 days of marketing exclusivity for the 500 mg strength, which it will begin to ship Feb. 2. Mylan was the first company to file a substantially complete ANDA containing a Paragraph IV certification for the 500 mg strength. Mylan is shipping the 250 mg strength immediately.

Divalproex ER Tablets are the generic version of Abbott Laboratories' Depakote(R) ER and had U.S. sales of approximately $901 million for the 12 months ending Sept. 30, 2008, with $789 million for the 500 mg strength and $112 million for the 250 mg strength.

Currently, Mylan has 119 ANDAs pending FDA approval, 33 of which are potential first-to-file opportunities.

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.


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

Page: 1

Related medicine news :

1. Mylan Declares Quarterly Preferred Stock Dividend
2. Mylan Receives Final FDA Approvals for Generic Versions of Lamictal(R) Tablets and Lamictal(R) CD
3. Mylan Receives Final FDA Approval for Generic Version of Prilosec(R) Delayed-Release Capsules, 40 mg
4. U.S. Patent and Trademark Office Issues Mylans Specialty Division, Dey L.P., Three Additional Patents Protecting Perforomist(R) Inhalation Solution
5. Mylan to Present at the 27th Annual J.P. Morgan Healthcare Conference
6. Mylans Matrix Receives Final FDA Approval for the Generic Version of the Antiretroviral Zerit(R) Capsules
7. Mylan Announces Move to NASDAQ Stock Market
8. Mylan Announces Settlement Agreement with Novartis Related to Femara(R) First- to-File Opportunity
9. Mylan Receives Final FDA Approval for the Generic Version of the Antidepressant Sarafem(R) Pulvules(R) Capsules
10. Mylan Receives Final Approval for First-to-File Generic Version of Antiepileptic Keppra(R) and Launches Immediately
11. Mylan Declares Quarterly Preferred Stock Dividend
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/25/2017)... ... 25, 2017 , ... The Byron Eaton Agency, a Birmingham based firm that ... organizing a local charity drive to send money and support to families in the ... have fallen on Houston as a result of Hurricane Harvey, raising water levels by ...
(Date:9/25/2017)... Wenatchee, WA (PRWEB) , ... September 25, 2017 , ... ... tracks. The project is live on crowdfunding platform Kickstarter seeking support for ... every 6 devices has fecal matter. All shockingly revolting, yet true. The Panther iPhone ...
(Date:9/25/2017)... (PRWEB) , ... September 25, 2017 , ... ... , an international competition, were announced on Friday, September 22 during a gala ... the human resources professionals, teams, achievements and HR-related products and suppliers who help ...
(Date:9/25/2017)... Somerset, N.J. (PRWEB) , ... September 25, 2017 ... ... advanced delivery technologies and development solutions for drugs, biologics and consumer health products, ... workshops on the development and validation of bioassays at two upcoming conferences. , ...
(Date:9/25/2017)... , ... September 25, 2017 , ... ... expand its Portable, Continuous, Miniature, and Modular (PCMM) collaboration with Pfizer and GEA ... Oral Solid Dosage line. The new PODs will provide tablet coating capability in ...
Breaking Medicine News(10 mins):
(Date:9/18/2017)... KALAMAZOO, Mich. , Sept. 18, 2017 /PRNewswire/ ... and OptiMed Specialty Pharmacy of Kalamazoo, Mich. ... a strategic hub service that expedites and streamlines patient ... spirometer, Spiro PD 2.0, and wellness management services.  ... a medical device used to measure lung function for ...
(Date:9/12/2017)... Sept. 12, 2017  ValGenesis Inc., the global ... is pleased to announce the appointment of Dr. ... its Board of Directors and Chairman of Advisory ... life science companies to manage their entire validation ... paper in this process. Furthermore, ValGenesis VLMS enables ...
(Date:9/7/2017)... RANCHO MIRAGE, Calif. , Sept. 7, 2017  For nearly two ... and service in the Assisted Reproduction Insurance industry. Today, New Life Agency ... expensive fertility medications. ... http://pharmacarecard.com/ (PRNewsfoto/PharmaCareCard) ... ...
Breaking Medicine Technology: