Navigation Links
Mylan Launches First Generic Version of Entocort EC® Capsules
Date:6/23/2011

PITTSBURGH, June 23, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that the U.S. District Court for the District of Delaware has found after trial that Mylan subsidiary Mylan Pharmaceuticals Inc. does not infringe the asserted claims of U.S. Patent No. 5,643,602 with its Abbreviated New Drug Application (ANDA) for Budesonide Capsules, 3 mg (Enteric Coated), the generic version of AstraZeneca's Entocort EC® capsules, a treatment for Crohn's disease.  

Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Budesonide Capsules, 3 mg, ANDA on May 16. This is the first generic version of this product to be introduced to the U.S. market, and Mylan Pharmaceuticals will be shipping this product immediately.

Budesonide Capsules, 3 mg, had U.S. sales of approximately $350 million for the 12 months ending March 31, 2011, according to IMS Health.

Currently, Mylan has 164 ANDAs pending FDA approval representing $94.2 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2010, 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 150 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 about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.


'/>"/>
SOURCE Mylan Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Mylan Receives Approval for Generic Version of Aricept® Tablets
2. Mylan Receives Approval for Generic Version of Effexor XR® Capsules
3. Mylan Launches Generic Version of Roxicodone® Tablets
4. Mylan Launches Generic Version of Depakote® Sprinkle Capsules
5. Mylan Launches First Generic Version of Xibrom® Ophthalmic Solution
6. Mylan Launches First Generic Version of Amrix® Capsules
7. Mylan Launches Generic Version of Risperdal® M-Tab®
8. Mylan Launches First Generic Version of Femara® Tablets
9. Mylan Launches Generic Version of Famvir® Tablets
10. Mylan Receives Approval for Generic Version of Xalatan® Ophthalmic Solution
11. Mylan Announces Exclusive Distribution Partnership with Humeca to Expand Burn and Wound Care Portfolio
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/4/2017)... , Oct. 4, 2017 ... single-use, self-contained, illuminating medical devices, today announced regulatory ... Health Surveillance Agency (or Agência Nacional de Vigilância ... first single-use, cordless surgical retractor with integrated LED ... optimal access, illumination and exposure of a tissue ...
(Date:10/2/2017)... , Oct. 2, 2017  Eli Lilly and ... financial results for the third quarter of 2017 on ... conference call on that day with the investment community ... The conference call will begin at 9 ... can access a live webcast of the conference call ...
(Date:10/2/2017)... announces the European launch of their new low volume, high throughput ... Cambridge, U.K on October 4th. The new ... unprecedented speed and sensitivity while using far less sample volume through ... ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance that ... insurance companies have a waiver for care if the client has a cognitive impairment ... family pays for care, is often waived, so the benefits from their insurance start ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... will be giving viewers the lowdown on sciatica in a new episode of ... that focuses on current events and innovation and investigates each subject in-depth with ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San Francisco ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are estimated ... in breathing. Oral appliances can offer significant relief to about 75 percent of ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally recognized health ... expanded their existing home health joint venture through an agreement, effective October 1, ... joint venture home health company with Asante, delivering clinically integrated care, for the ...
(Date:10/12/2017)... ... 12, 2017 , ... On Saturday, October 21, the Health & Wellness Center ... to raise money for the American Heart Association Heart Walk. Teams of up to ... together to keep their treadmills moving for 5 hours. Treadmills will start at 7:00 ...
Breaking Medicine News(10 mins):