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:12/4/2016)... , ... December 03, 2016 , ... While James Earl ... serving as host for in a show called "Front Page". One of the forthcoming ... years, breast cancer rates have plummeted in large part due to early detection. Like ...
(Date:12/4/2016)... ... December 04, 2016 , ... Patients who wish to ... advantage of a cosmetic procedure known as Carbon Dioxide (C02) Fractional Laser ... of age spots, fine lines, uneven coloration, wrinkles, scarring, skin laxity or ...
(Date:12/2/2016)... ... December 02, 2016 , ... Lori G. Cohen and ... will speak at the American Conference Institute’s 21st Drug & Medical Device Litigation ... Lead Sponsor of the conference. , Cohen, who chairs the firm’s Pharmaceutical, Medical Device ...
(Date:12/2/2016)... ... December 02, 2016 , ... More than 100 business, civic, ... to attend the UNCF Dothan-Wiregrass Mayor’s Luncheon Dec. 9, 2016. This inaugural event, ... and operating support to UNCF-member institutions, including Miles College, Oakwood University, Tuskegee University, ...
(Date:12/2/2016)... ... , ... The annual time frame to change Medicare health and prescription drug ... 7th. Currently-enrolled Medicare beneficiaries who are looking to switch from their current plan to ... make changes during this period order for their new policy to go into effect ...
Breaking Medicine News(10 mins):
(Date:12/4/2016)... 2016  Results from the Phase II SUSTAIN study ... reduced the median annual rate of sickle cell-related pain ... 2.98, p=0.010) in patients with or without hydroxyurea therapy ... being featured in the official press briefing at the ... Meeting and presented during the Plenary Scientific Session tomorrow ...
(Date:12/2/2016)... December 2, 2016 - bioLytical lanza el INSTI HIV ... la OMS     Continue Reading ... ... , , bioLytical ... anunciado hoy que está expandiendo el lanzamiento de su INSTI HIV Self Test ...
(Date:12/2/2016)... December 2, 2016 According to the ... Market Study on Automated Endoscope Reprocessors: Single Basin Automated Endoscope ... 8.6% Between 2016 and 2024 " the global automated endoscope reprocessors market was ... to expand at a CAGR of 7.2% during an eight-year ... 1,367.6 Mn by 2024. ...
Breaking Medicine Technology: