Navigation Links
Mylan Receives Approval for Nabumetone Tablets

PITTSBURGH, July 14 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nabumetone Tablets USP, 500 mg and 750 mg. The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Nabumetone Tablets, a treatment for osteoarthritis and rheumatoid arthritis. The product will be distributed by Mylan Pharmaceuticals Inc.

Nabumetone Tablets had U.S. sales of approximately $68 million for the 12 months ending March 31, 2010, according to IMS Health.

Currently, Mylan has 134 ANDAs pending FDA approval representing $93.8 billion in annual brand sales, according to IMS Health. Thirty-nine of these pending ANDAs are potential first-to-file opportunities, representing $20.2 billion in annual brand sales, for the 12 months ending Dec. 31, 2009 according to IMS Health.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit

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

Related medicine technology :

1. Mylan Schedules Second Quarter 2010 Financial Results Conference Call and Live Webcast
2. Mylan Receives Approval for Generic Version of Arimidex® Tablets
3. Mylan Receives Approval for Generic Version of Zocor® Tablets
4. Mylan Receives Approval for Hydroxyzine Hydrochloride Tablets
5. Mylan Receives Approval for Generic Version of Neurontin® Tablets
6. Mylan Receives Approval for Generic Version of Valtrex®
7. Mylan Launches Temazepam Capsules USP, 7.5 mg
8. Mylan Announces Completion of Senior Notes Offering
9. Mylan Announces Upsizing and Pricing of Senior Notes
10. Mylan Announces Proposed Senior Notes Private Placement
11. Mylan Receives Approval for Generic Version of Zyban(R)
Post Your Comments:
(Date:11/24/2015)... Nov. 24, 2015 iRhythm Technologies, Inc. , a ... today announced that it will participate in the 27th Annual Piper ... New York, NY . Kevin King , ... December 1, 2015 at 8:50am ET. --> ... . --> . --> iRhythm ...
(Date:11/24/2015)... Ontario , Nov. 24, 2015 Teledyne ... digital X-Ray image sensing technology, will introduce its CMOS ... Technical Exhibition , November 29 to December 3, at McCormick ... of dynamic detectors for diagnostic and interventional imaging will be ... Xineos family of advanced CMOS X-Ray detectors is ...
(Date:11/24/2015)... The uptake of recently approved and pipeline premium products for ... growth to 2021, says GBI Research . ... Type 1 Diabetes Mellitus (T1DM), will be a key driver of market ... --> The uptake of recently approved and pipeline premium products ... market growth to 2021, says GBI Research . ...
Breaking Medicine Technology:
(Date:11/24/2015)... , ... November 24, 2015 , ... It takes only ... a business, it is critical that the first impression be positive and reflects business ... not likely to buy anything or want to return. They will also share their ...
(Date:11/24/2015)... ... 24, 2015 , ... United Benefit Advisors (UBA), the nation’s ... as its newest Partner Firm. Based in Jefferson City, Missouri, their core philosophy ... regardless of whether that client is a business, a family, or an individual. ...
(Date:11/24/2015)... , ... November 24, 2015 , ... Serenity Point Rehabilitation, ... series of recent video interviews with some of the staff members at their recovery ... residential treatment facility, as well as some of the things that make their recovery ...
(Date:11/24/2015)... ... 2015 , ... Abington Hospital – Jefferson Health is pleased ... Surgery Facility for treating individuals living with morbid or extreme obesity. , Aetna ... its members to help them make informed decisions about their healthcare needs. In ...
(Date:11/24/2015)... ... November 24, 2015 , ... American Specialty ... Program have announced their endorsement of the Medical Fitness Network (MFN), a ... proud to have the MFN as one of our endorsed organizations,” said ASH ...
Breaking Medicine News(10 mins):